Medications & Supplements/Prescription Drugs

Zydus Pharmaceuticals USA Inc: Anastrozole, Pramipexole, and Methylprednisolone Recalled for Cross-Contamination

Agency Publication Date: July 1, 2019

Summary

Zydus Pharmaceuticals USA Inc. is recalling 2,206,591 units of various prescription medications, including Anastrozole, Pramipexole Dihydrochloride, and Methylprednisolone Tablets, due to a cleaning failure at the manufacturing facility. This failure led to deviations from Current Good Manufacturing Practices (CGMP) and resulted in the cross-contamination of these drugs with other products. Consumers should check their medicine bottles for the specific lot numbers and expiration dates listed below to determine if their medication is affected.

Risk

Cross-contamination means that these tablets may contain unintended pharmaceutical ingredients from other products manufactured on the same equipment. Taking a medication contaminated with an unknown drug substance could lead to unexpected side effects, allergic reactions, or dangerous drug interactions.

What You Should Do

Check your medication bottles for the following NDC numbers: Anastrozole (68382-209-06, 68382-209-10), Pramipexole (68382-196-10, 68382-196-16, 68382-197-16, 68382-197-10, 68382-198-16, 68382-199-16, 68382-200-16), or Methylprednisolone (68382-916-01, 68382-916-34, 68382-918-18, 68382-919-11, 68382-917-11).
Verify if your lot number and expiration date match the extensive list of affected batches, such as Anastrozole lot M706674 (Exp 06/19) or Methylprednisolone lot M903484 (Exp 03/21).
Contact your healthcare provider or pharmacist immediately to discuss your treatment and obtain a safe replacement medication.
Do not stop taking your prescribed medication without consulting a healthcare professional first, as abruptly stopping some of these drugs can cause health complications.
Return any unused portions of the recalled medication to your pharmacy for a refund and to ensure proper disposal.
Contact Zydus Pharmaceuticals USA Inc. at their Pennington, New Jersey office for further information regarding this recall.
For additional questions, contact the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls.

Your Remedy Options

Full Refund

Return unused product for a refund.

How to: Contact your healthcare provider or pharmacist for guidance. Return any unused product to the pharmacy for a refund

Affected Products

Product: ANASTROZOLE Tablets, 1 mg (30-count bottle)

Model:

NDC 68382-209-06

Lot Numbers (52):

M706674 (Exp Jun-19)

M706676 (Exp Jun-19)

M707685 (Exp Jun-19)

M711219 (Exp Sep-19)

M711220 (Exp Sep-19)

M711221 (Exp Sep-19)

M711222 (Exp Sep-19)

M711269 (Exp Sep-19)

M801027 (Exp Dec-19)

M801028 (Exp Jan-20)

M801029 (Exp Jan-20)

M801030 (Exp Jan-20)

M802206 (Exp Feb-20)

M805195 (Exp Mar-20)

M805196 (Exp Mar-20)

M805197 (Exp Mar-20)

M805199 (Exp Apr-20)

M805202 (Exp Apr-20)

M805944 (Exp Apr-20)

M805945 (Exp Apr-20)

M805948 (Exp Apr-20)

M805951 (Exp Apr-20)

M805953 (Exp Apr-20)

M805956 (Exp Apr-20)

M805957 (Exp Apr-20)

M805958 (Exp Apr-20)

M805959 (Exp Apr-20)

M812457 (Exp Jul-20)

M812458 (Exp Aug-20)

M812459 (Exp Aug-20)

M813912 (Exp Aug-20)

M813913 (Exp Aug-20)

M813914 (Exp Aug-20)

M813915 (Exp Aug-20)

M813916 (Exp Aug-20)

M815768 (Exp Oct-20)

M815769 (Exp Oct-20)

M818274 (Exp Oct-20)

M818119 (Exp Nov-20)

M818120 (Exp Nov-20)

M818121 (Exp Nov-20)

M818635 (Exp Nov-20)

M819270 (Exp Dec-20)

M819861 (Exp Dec-20)

M819862 (Exp Dec-20)

M900921 (Exp Jan-21)

M900922 (Exp Jan-21)

M900923 (Exp Jan-21)

M900924 (Exp Jan-21)

M900925 (Exp Jan-21)

Date Ranges: Jun-19, Sep-19, Dec-19, Jan-20, Feb-20, Mar-20, Apr-20, Jul-20, Aug-20, Oct-20, Nov-20, Dec-20, Jan-21, Feb-21

Product: Anastrozole Tablets, USP, 1 mg (1,000-count bottle)

Model:

NDC 68382-209-10

Lot Numbers:

M708570 (Exp Jun-19)

M711270 (Exp Sep-19)

M802207 (Exp Feb-20)

M812460 (Exp Aug-20)

Date Ranges: Jun-19, Sep-19, Feb-20, Aug-20

Product: Pramipexole Dihydrochloride Tablets 0.125 mg (1,000-count bottle)

Model:

NDC 68382-196-10

Lot Numbers:

M714919 (Exp Dec-19)

M815081 (Exp Aug-20)

M900475 (Exp Dec-20)

Date Ranges: Dec-19, Aug-20, Dec-20

Product: Pramipexole Dihydrochloride Tablets 0.125 mg (90-count bottle)

Model:

NDC 68382-196-16

Lot Numbers:

M714176 (Exp Oct-19)

M714177 (Exp Oct-19)

M714917 (Exp Nov-19)

M714918 (Exp Dec-19)

M715594 (Exp Dec-19)

M715595 (Exp Dec-19)

M802190 (Exp Jan-20)

M802191 (Exp Feb-20)

M808673 (Exp May-20)

M811125 (Exp Jun-20)

M811126 (Exp Jun-20)

M811127 (Exp Jun-20)

M811128 (Exp Jun-20)

M811129 (Exp Jun-20)

M815082 (Exp Aug-20)

M815083 (Exp Aug-20)

M815084 (Exp Aug-20)

M815085 (Exp Aug-20)

M815086 (Exp Aug-20)

M900476 (Exp Dec-20)

M900477 (Exp Dec-20)

M900478 (Exp Dec-20)

M900479 (Exp Dec-20)

M900481 (Exp Dec-20)

Date Ranges: Oct-19, Nov-19, Dec-19, Jan-20, Feb-20, May-20, Jun-20, Aug-20, Dec-20

Product: Pramipexole Dihydrochoride Tablets 0.25 mg (90-count bottle)

Model:

NDC 68382-197-16

Lot Numbers:

M706802 (Exp May-19)

M706804 (Exp May-19)

M706907 (Exp May-19)

M706909 (Exp May-19)

M707028 (Exp May-19)

M714180 (Exp Oct-19)

M714181 (Exp Oct-19)

M717063 (Exp Dec-19)

M717064 (Exp Dec-19)

M801705 (Exp Dec-19)

M801706 (Exp Dec-19)

M801707 (Exp Dec-19)

M801708 (Exp Dec-19)

M714923 (Exp Dec-19)

M714924 (Exp Dec-19)

M714925 (Exp Dec-19)

M808307 (Exp May-20)

M808308 (Exp May-20)

M808309 (Exp May-20)

M808310 (Exp May-20)

M812479 (Exp Jul-20)

M812481 (Exp Jul-20)

M812482 (Exp Jul-20)

M812483 (Exp Jul-20)

M815787 (Exp Sep-20)

M815789 (Exp Sep-20)

M815790 (Exp Sep-20)

M815791 (Exp Sep-20)

M815788 (Exp Sep-20)

M820266 (Exp Nov-20)

M820267 (Exp Nov-20)

M820268 (Exp Nov-20)

M820269 (Exp Nov-20)

M820265 (Exp Nov-20)

M903040 (Exp Jan-21)

M903041 (Exp Jan-21)

M903042 (Exp Jan-21)

Date Ranges: May-19, Oct-19, Dec-19, May-20, Jul-20, Sep-20, Nov-20, Jan-21

Product: Pramipexole Dihydrochloride Tablets 0.25 mg (1000-count bottle)

Model:

NDC 68382-197-10

Lot Numbers:

M706803 (Exp Jun-19)

M713438 (Exp Oct-19)

M801704 (Exp Jan-20)

M808306 (Exp Jun-20)

M812484 (Exp Aug-20)

M820264 (Exp Dec-20)

Date Ranges: Jun-19, Oct-19, Jan-20, Jun-20, Aug-20, Dec-20

Product: Pramipexole Dihydrochloride Tablets 0.5 mg (90-count bottle)

Model:

NDC 68382-198-16

Lot Numbers:

M713431 (Exp Sep-19)

M713432 (Exp Sep-19)

M714172 (Exp Sep-19)

M714173 (Exp Oct-19)

M800552 (Exp Dec-19)

M800553 (Exp Dec-19)

M800554 (Exp Dec-19)

M800555 (Exp Dec-19)

M800556 (Exp Dec-19)

M811135 (Exp Jun-20)

M812818 (Exp Jun-20)

M812819 (Exp Jun-20)

M812820 (Exp Jun-20)

M812821 (Exp Jun-20)

M815777 (Exp Aug-20)

M815778 (Exp Aug-20)

M815779 (Exp Aug-20)

M815780 (Exp Aug-20)

M815781 (Exp Aug-20)

M901927 (Exp Jan-21)

M901929 (Exp Jan-21)

M901931 (Exp Jan-21)

M901933 (Exp Jan-21)

M902089 (Exp Jan-21)

Date Ranges: Sep-19, Oct-19, Dec-19, Jun-20, Aug-20, Jan-21

Product: Pramipexole Dihydrochloride Tablets 1 mg (90-count bottle)

Model:

NDC 68382-199-16

Lot Numbers:

M714186 (Exp Oct-19)

M714187 (Exp Oct-19)

M714188 (Exp Oct-19)

M714903 (Exp Nov-19)

M714904 (Exp Nov-19)

M714905 (Exp Nov-19)

M715586 (Exp Nov-19)

M715587 (Exp Nov-19)

M801441 (Exp Dec-19)

M801442 (Exp Dec-19)

M801443 (Exp Dec-19)

M801444 (Exp Dec-19)

M801445 (Exp Dec-19)

M811152 (Exp Jul-20)

M811153 (Exp Jul-20)

M811154 (Exp Jul-20)

M811155 (Exp Jul-20)

M811156 (Exp Jul-20)

M814298 (Exp Jul-20)

M814299 (Exp Aug-20)

M814300 (Exp Aug-20)

M814301 (Exp Aug-20)

M814302 (Exp Aug-20)

M818136 (Exp Nov-20)

M818137 (Exp Nov-20)

M818138 (Exp Nov-20)

M818139 (Exp Nov-20)

M818140 (Exp Nov-20)

Date Ranges: Oct-19, Nov-19, Dec-19, Jul-20, Aug-20, Nov-20

Product: MethylPREDNISolone Tablets, USP, 4 mg (100-count bottle)

Model:

NDC 68382-916-01

Lot Numbers:

M800144 (Exp Feb-20)

M800145 (Exp Feb-20)

M808193 (Exp Jun-20)

M811096 (Exp Jul-20)

Date Ranges: Feb-20, Jun-20, Jul-20

Product: MethylPREDNISolone Tablets, USP, 4 mg (21 Tablets dosepack)

Model:

NDC 68382-916-34

Lot Numbers (51):

M800150 (Exp Feb-20)

M803930 (Exp Mar-20)

M806006 (Exp Mar-20)

M806007 (Exp Mar-20)

M806008 (Exp Mar-20)

M806009 (Exp Mar-20)

M806010 (Exp Mar-20)

M806011 (Exp Mar-20)

M807299 (Exp May-20)

M807300 (Exp May-20)

M807301 (Exp May-20)

M807302 (Exp May-20)

M807303 (Exp May-20)

M807304 (Exp May-20)

M807305 (Exp May-20)

M807306 (Exp May-20)

M807307 (Exp May-20)

M807308 (Exp May-20)

M807779 (Exp Jun-20)

M807780 (Exp Jun-20)

M808194 (Exp Jun-20)

M808195 (Exp Jun-20)

M808196 (Exp Jun-20)

M808197 (Exp Jun-20)

M808198 (Exp Jun-20)

M811092 (Exp Jul-20)

M811093 (Exp Jul-20)

M811094 (Exp Jul-20)

M811097 (Exp Jul-20)

M811665 (Exp Jul-20)

M811666 (Exp Jul-20)

M811667 (Exp Jul-20)

M813781 (Exp Jul-20)

M816286 (Exp Oct-20)

M816288 (Exp Oct-20)

M816289 (Exp Oct-20)

M816290 (Exp Oct-20)

M817612 (Exp Oct-20)

M817613 (Exp Nov-20)

M817614 (Exp Nov-20)

M817615 (Exp Nov-20)

M817616 (Exp Nov-20)

M818315 (Exp Nov-20)

M820619 (Exp Mar-21)

M820620 (Exp Mar-21)

M820621 (Exp Mar-21)

M901594 (Exp Mar-21)

M901595 (Exp Mar-21)

M901596 (Exp Mar-21)

M901597 (Exp Mar-21)

Date Ranges: Feb-20, Mar-20, May-20, Jun-20, Jul-20, Oct-20, Nov-20, Mar-21

Product: MethylPREDNISolone Tablets, USP 16 mg (50-count bottle)

Model:

NDC 68382-918-18

Lot Numbers:

M713034 (Exp Nov-19)

M713035 (Exp Nov-19)

M713036 (Exp Nov-19)

M814747 (Exp Sep-20)

M819266 (Exp Dec-20)

Date Ranges: Nov-19, Sep-20, Dec-20

Product: MethylPREDNISolone Tablets, USP 32 mg (25-count bottle)

Model:

NDC 68382-919-11

Lot Numbers:

M713043 (Exp Dec-19)

M713047 (Exp Dec-19)

M713045 (Exp Nov-19)

M816143 (Exp Oct-20)

Date Ranges: Nov-19, Dec-19, Oct-20

Product: Pramipexole Dihydrochloride Tablets 1.5 mg (90-count bottle)

Model:

NDC 68382-200-16

Lot Numbers:

M713435 (Exp Sep-19)

M713436 (Exp Sep-19)

M714191 (Exp Oct-19)

M808185 (Exp May-20)

M808184 (Exp May-20)

M808186 (Exp May-20)

M817634 (Exp Nov-20)

M817635 (Exp Nov-20)

Date Ranges: Sep-19, Oct-19, May-20, Nov-20

Product: MethylPREDNISolone Tablets, USP 8 mg (25-count bottle)

Model:

NDC 68382-917-11

Lot Numbers:

M713224 (Exp Nov-19)

M713225 (Exp Nov-19)

M713226 (Exp Nov-19)

M814746 (Exp Sep-20)

M816148 (Exp Oct-20)

M901600 (Exp Feb-21)

M901601 (Exp Feb-21)

Date Ranges: Nov-19, Sep-20, Oct-20, Feb-21

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 82827

Status: Resolved

Manufacturer: Zydus Pharmaceuticals USA Inc

Sold By: Pharmacies nationwide

Manufactured In: India, United States

Units Affected: 12 products (1,425,264 30-count bottles; 768 1000-count bottles; 204 1000-count bottles; 143,184 90-count bottles; 215,760 90-count bottles; 3,156 1000-count bottles; 168,330 90-count bottles; 113,304 90-count bottles; 34521 100-count bottles; 13,564 25-count bottles; 47,664 90-count bottles; 40872 25-count bottles)

Distributed To: Nationwide

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.

Summary

Risk

What You Should Do

Check your medication bottles for the following NDC numbers: Anastrozole (68382-209-06, 68382-209-10), Pramipexole (68382-196-10, 68382-196-16, 68382-197-16, 68382-197-10, 68382-198-16, 68382-199-16, 68382-200-16), or Methylprednisolone (68382-916-01, 68382-916-34, 68382-918-18, 68382-919-11, 68382-917-11).

Verify if your lot number and expiration date match the extensive list of affected batches, such as Anastrozole lot M706674 (Exp 06/19) or Methylprednisolone lot M903484 (Exp 03/21).

Contact your healthcare provider or pharmacist immediately to discuss your treatment and obtain a safe replacement medication.

Do not stop taking your prescribed medication without consulting a healthcare professional first, as abruptly stopping some of these drugs can cause health complications.

Return any unused portions of the recalled medication to your pharmacy for a refund and to ensure proper disposal.

Contact Zydus Pharmaceuticals USA Inc. at their Pennington, New Jersey office for further information regarding this recall.

For additional questions, contact the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls.

Affected Products

Product: ANASTROZOLE Tablets, 1 mg (30-count bottle)

Model:

NDC 68382-209-06

Lot Numbers (52):

M706674 (Exp Jun-19)

M706676 (Exp Jun-19)

M707685 (Exp Jun-19)

M711219 (Exp Sep-19)

M711220 (Exp Sep-19)

M711221 (Exp Sep-19)

M711222 (Exp Sep-19)

M711269 (Exp Sep-19)

M801027 (Exp Dec-19)

M801028 (Exp Jan-20)

M801029 (Exp Jan-20)

M801030 (Exp Jan-20)

M802206 (Exp Feb-20)

M805195 (Exp Mar-20)

M805196 (Exp Mar-20)

M805197 (Exp Mar-20)

M805199 (Exp Apr-20)

M805202 (Exp Apr-20)

M805944 (Exp Apr-20)

M805945 (Exp Apr-20)

M805948 (Exp Apr-20)

M805951 (Exp Apr-20)

M805953 (Exp Apr-20)

M805956 (Exp Apr-20)

M805957 (Exp Apr-20)

M805958 (Exp Apr-20)

M805959 (Exp Apr-20)

M812457 (Exp Jul-20)

M812458 (Exp Aug-20)

M812459 (Exp Aug-20)

M813912 (Exp Aug-20)

M813913 (Exp Aug-20)

M813914 (Exp Aug-20)

M813915 (Exp Aug-20)

M813916 (Exp Aug-20)

M815768 (Exp Oct-20)

M815769 (Exp Oct-20)

M818274 (Exp Oct-20)

M818119 (Exp Nov-20)

M818120 (Exp Nov-20)

M818121 (Exp Nov-20)

M818635 (Exp Nov-20)

M819270 (Exp Dec-20)

M819861 (Exp Dec-20)

M819862 (Exp Dec-20)

M900921 (Exp Jan-21)

M900922 (Exp Jan-21)

M900923 (Exp Jan-21)

M900924 (Exp Jan-21)

M900925 (Exp Jan-21)

Date Ranges: Jun-19, Sep-19, Dec-19, Jan-20, Feb-20, Mar-20, Apr-20, Jul-20, Aug-20, Oct-20, Nov-20, Dec-20, Jan-21, Feb-21

Product: Anastrozole Tablets, USP, 1 mg (1,000-count bottle)

Model:

NDC 68382-209-10

Lot Numbers:

M708570 (Exp Jun-19)

M711270 (Exp Sep-19)

M802207 (Exp Feb-20)

M812460 (Exp Aug-20)

Date Ranges: Jun-19, Sep-19, Feb-20, Aug-20

Product: Pramipexole Dihydrochloride Tablets 0.125 mg (1,000-count bottle)

Model:

NDC 68382-196-10

Lot Numbers:

M714919 (Exp Dec-19)

M815081 (Exp Aug-20)

M900475 (Exp Dec-20)

Date Ranges: Dec-19, Aug-20, Dec-20

Product: Pramipexole Dihydrochloride Tablets 0.125 mg (90-count bottle)

Model:

NDC 68382-196-16

Lot Numbers:

M714176 (Exp Oct-19)

M714177 (Exp Oct-19)

M714917 (Exp Nov-19)

M714918 (Exp Dec-19)

M715594 (Exp Dec-19)

M715595 (Exp Dec-19)

M802190 (Exp Jan-20)

M802191 (Exp Feb-20)

M808673 (Exp May-20)

M811125 (Exp Jun-20)

M811126 (Exp Jun-20)

M811127 (Exp Jun-20)

M811128 (Exp Jun-20)

M811129 (Exp Jun-20)

M815082 (Exp Aug-20)

M815083 (Exp Aug-20)

M815084 (Exp Aug-20)

M815085 (Exp Aug-20)

M815086 (Exp Aug-20)

M900476 (Exp Dec-20)

M900477 (Exp Dec-20)

M900478 (Exp Dec-20)

M900479 (Exp Dec-20)

M900481 (Exp Dec-20)

Date Ranges: Oct-19, Nov-19, Dec-19, Jan-20, Feb-20, May-20, Jun-20, Aug-20, Dec-20

Product: Pramipexole Dihydrochoride Tablets 0.25 mg (90-count bottle)

Model:

NDC 68382-197-16

Lot Numbers:

M706802 (Exp May-19)

M706804 (Exp May-19)

M706907 (Exp May-19)

M706909 (Exp May-19)

M707028 (Exp May-19)

M714180 (Exp Oct-19)

M714181 (Exp Oct-19)

M717063 (Exp Dec-19)

M717064 (Exp Dec-19)

M801705 (Exp Dec-19)

M801706 (Exp Dec-19)

M801707 (Exp Dec-19)

M801708 (Exp Dec-19)

M714923 (Exp Dec-19)

M714924 (Exp Dec-19)

M714925 (Exp Dec-19)

M808307 (Exp May-20)

M808308 (Exp May-20)

M808309 (Exp May-20)

M808310 (Exp May-20)

M812479 (Exp Jul-20)

M812481 (Exp Jul-20)

M812482 (Exp Jul-20)

M812483 (Exp Jul-20)

M815787 (Exp Sep-20)

M815789 (Exp Sep-20)

M815790 (Exp Sep-20)

M815791 (Exp Sep-20)

M815788 (Exp Sep-20)

M820266 (Exp Nov-20)

M820267 (Exp Nov-20)

M820268 (Exp Nov-20)

M820269 (Exp Nov-20)

M820265 (Exp Nov-20)

M903040 (Exp Jan-21)

M903041 (Exp Jan-21)

M903042 (Exp Jan-21)

Date Ranges: May-19, Oct-19, Dec-19, May-20, Jul-20, Sep-20, Nov-20, Jan-21

Product: Pramipexole Dihydrochloride Tablets 0.25 mg (1000-count bottle)

Model:

NDC 68382-197-10

Lot Numbers:

M706803 (Exp Jun-19)

M713438 (Exp Oct-19)

M801704 (Exp Jan-20)

M808306 (Exp Jun-20)

M812484 (Exp Aug-20)

M820264 (Exp Dec-20)

Date Ranges: Jun-19, Oct-19, Jan-20, Jun-20, Aug-20, Dec-20

Product: Pramipexole Dihydrochloride Tablets 0.5 mg (90-count bottle)

Model:

NDC 68382-198-16

Lot Numbers:

M713431 (Exp Sep-19)

M713432 (Exp Sep-19)

M714172 (Exp Sep-19)

M714173 (Exp Oct-19)

M800552 (Exp Dec-19)

M800553 (Exp Dec-19)

M800554 (Exp Dec-19)

M800555 (Exp Dec-19)

M800556 (Exp Dec-19)

M811135 (Exp Jun-20)

M812818 (Exp Jun-20)

M812819 (Exp Jun-20)

M812820 (Exp Jun-20)

M812821 (Exp Jun-20)

M815777 (Exp Aug-20)

M815778 (Exp Aug-20)

M815779 (Exp Aug-20)

M815780 (Exp Aug-20)

M815781 (Exp Aug-20)

M901927 (Exp Jan-21)

M901929 (Exp Jan-21)

M901931 (Exp Jan-21)

M901933 (Exp Jan-21)

M902089 (Exp Jan-21)

Date Ranges: Sep-19, Oct-19, Dec-19, Jun-20, Aug-20, Jan-21

Product: Pramipexole Dihydrochloride Tablets 1 mg (90-count bottle)

Model:

NDC 68382-199-16

Lot Numbers:

M714186 (Exp Oct-19)

M714187 (Exp Oct-19)

M714188 (Exp Oct-19)

M714903 (Exp Nov-19)

M714904 (Exp Nov-19)

M714905 (Exp Nov-19)

M715586 (Exp Nov-19)

M715587 (Exp Nov-19)

M801441 (Exp Dec-19)

M801442 (Exp Dec-19)

M801443 (Exp Dec-19)

M801444 (Exp Dec-19)

M801445 (Exp Dec-19)

M811152 (Exp Jul-20)

M811153 (Exp Jul-20)

M811154 (Exp Jul-20)

M811155 (Exp Jul-20)

M811156 (Exp Jul-20)

M814298 (Exp Jul-20)

M814299 (Exp Aug-20)

M814300 (Exp Aug-20)

M814301 (Exp Aug-20)

M814302 (Exp Aug-20)

M818136 (Exp Nov-20)

M818137 (Exp Nov-20)

M818138 (Exp Nov-20)

M818139 (Exp Nov-20)

M818140 (Exp Nov-20)

Date Ranges: Oct-19, Nov-19, Dec-19, Jul-20, Aug-20, Nov-20

Product: MethylPREDNISolone Tablets, USP, 4 mg (100-count bottle)

Model:

NDC 68382-916-01

Lot Numbers:

M800144 (Exp Feb-20)

M800145 (Exp Feb-20)

M808193 (Exp Jun-20)

M811096 (Exp Jul-20)

Date Ranges: Feb-20, Jun-20, Jul-20

Product: MethylPREDNISolone Tablets, USP, 4 mg (21 Tablets dosepack)

Model:

NDC 68382-916-34

Lot Numbers (51):

M800150 (Exp Feb-20)

M803930 (Exp Mar-20)

M806006 (Exp Mar-20)

M806007 (Exp Mar-20)

M806008 (Exp Mar-20)

M806009 (Exp Mar-20)

M806010 (Exp Mar-20)

M806011 (Exp Mar-20)

M807299 (Exp May-20)

M807300 (Exp May-20)

M807301 (Exp May-20)

M807302 (Exp May-20)

M807303 (Exp May-20)

M807304 (Exp May-20)

M807305 (Exp May-20)

M807306 (Exp May-20)

M807307 (Exp May-20)

M807308 (Exp May-20)

M807779 (Exp Jun-20)

M807780 (Exp Jun-20)

M808194 (Exp Jun-20)

M808195 (Exp Jun-20)

M808196 (Exp Jun-20)

M808197 (Exp Jun-20)

M808198 (Exp Jun-20)

M811092 (Exp Jul-20)

M811093 (Exp Jul-20)

M811094 (Exp Jul-20)

M811097 (Exp Jul-20)

M811665 (Exp Jul-20)

M811666 (Exp Jul-20)

M811667 (Exp Jul-20)

M813781 (Exp Jul-20)

M816286 (Exp Oct-20)

M816288 (Exp Oct-20)

M816289 (Exp Oct-20)

M816290 (Exp Oct-20)

M817612 (Exp Oct-20)

M817613 (Exp Nov-20)

M817614 (Exp Nov-20)

M817615 (Exp Nov-20)

M817616 (Exp Nov-20)

M818315 (Exp Nov-20)

M820619 (Exp Mar-21)

M820620 (Exp Mar-21)

M820621 (Exp Mar-21)

M901594 (Exp Mar-21)

M901595 (Exp Mar-21)

M901596 (Exp Mar-21)

M901597 (Exp Mar-21)

Date Ranges: Feb-20, Mar-20, May-20, Jun-20, Jul-20, Oct-20, Nov-20, Mar-21

Product: MethylPREDNISolone Tablets, USP 16 mg (50-count bottle)

Model:

NDC 68382-918-18

Lot Numbers:

M713034 (Exp Nov-19)

M713035 (Exp Nov-19)

M713036 (Exp Nov-19)

M814747 (Exp Sep-20)

M819266 (Exp Dec-20)

Date Ranges: Nov-19, Sep-20, Dec-20

Product: MethylPREDNISolone Tablets, USP 32 mg (25-count bottle)

Model:

NDC 68382-919-11

Lot Numbers:

M713043 (Exp Dec-19)

M713047 (Exp Dec-19)

M713045 (Exp Nov-19)

M816143 (Exp Oct-20)

Date Ranges: Nov-19, Dec-19, Oct-20

Product: Pramipexole Dihydrochloride Tablets 1.5 mg (90-count bottle)

Model:

NDC 68382-200-16

Lot Numbers:

M713435 (Exp Sep-19)

M713436 (Exp Sep-19)

M714191 (Exp Oct-19)

M808185 (Exp May-20)

M808184 (Exp May-20)

M808186 (Exp May-20)

M817634 (Exp Nov-20)

M817635 (Exp Nov-20)

Date Ranges: Sep-19, Oct-19, May-20, Nov-20

Product: MethylPREDNISolone Tablets, USP 8 mg (25-count bottle)

Model:

NDC 68382-917-11

Lot Numbers:

M713224 (Exp Nov-19)

M713225 (Exp Nov-19)

M713226 (Exp Nov-19)

M814746 (Exp Sep-20)

M816148 (Exp Oct-20)

M901600 (Exp Feb-21)

M901601 (Exp Feb-21)

Date Ranges: Nov-19, Sep-20, Oct-20, Feb-21

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 82827

Status: Resolved

Manufacturer: Zydus Pharmaceuticals USA Inc

Sold By: Pharmacies nationwide

Manufactured In: India, United States

Distributed To: Nationwide