Medications & Supplements/Prescription Drugs

KRS Global Biotechnology, Inc: Various Compounded Drugs Recalled Due to Incorrect Expiration Dates

Agency Publication Date: January 8, 2018

Summary

KRS Global Biotechnology, Inc. is recalling 97,236 units of various compounded medications, including capsules, creams, injectable vials, and ophthalmic solutions. These products were found to have 'Beyond Use Dates' (expiration dates) that incorrectly exceeded the expiration dates of the individual ingredients used to make the final medication. This means the drugs may have been labeled with a shelf life longer than their components could safely guarantee, potentially affecting the potency and safety of the medications.

Risk

Using medication past its actual stability date can lead to reduced effectiveness of the treatment or unforeseen chemical changes in the product. In this case, the final product's labeled expiration date was set further in the future than at least one of its active or inactive ingredients, which could compromise the drug's quality and therapeutic benefit.

What You Should Do

Check your medication packaging for the 'BUD' (Beyond Use Date) and Lot Number. Affected products include Anastrozole, Human Chorionic Gonadotropin (HCG), various 'QUADMIX' and 'Trimix' injections, and specialized creams and powders.
Identify if your product is included by matching the lot numbers and dates, such as Anastrozole 0.5 mg (Lot 03092017@21, BUD 3/9/2018), HCG 11,000 iu (Lot 06222017@10, BUD 12/19/2017), or Vitamin 10 B (Lot 05232017@13, BUD 11/19/2017).
Stop using any affected medication immediately if you identify a recalled lot number.
Contact your healthcare provider or pharmacist to discuss your treatment and determine if a replacement prescription is necessary.
Return any unused portion of the recalled medication to the pharmacy or place of purchase for a refund.
Contact KRS Global Biotechnology, Inc. at their distributor location in Boca Raton, Florida, for further instructions regarding this recall.
For additional questions or to report a complaint, contact the FDA Consumer Complaint hotline at 1-888-723-3332 or visit www.fda.gov/safety/recalls.

Your Remedy Options

Full Refund

Healthcare guidance and product 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 0.5 mg Capsules

Model:

D-0161-2018

Lot Numbers:

03092017@21

03292017@33

05092017@38

05162017@31

05182017@25

07032017@40

07142017@34

07192017@32

08282017@25

09142017@8

09212017@23

09272017@36

10162017@39

11032017@28

Date Ranges: 3/9/2018, 3/24/2018, 5/4/2018, 5/11/2018, 5/13/2018, 6/28/2018, 7/9/2018, 7/14/2018, 8/23/2018, 9/9/2018, 9/16/2018, 9/22/2018, 10/11/2018, 10/29/2018

Product: Amphotericin 60 mg/Chloramphenicol 600 mg/Hydrocortisone 10 mg Otic Powder

Model:

D-0162-2018

Lot Numbers:

07282017@25

Date Ranges: 1/24/2018

Product: Anastrozole SR 1 mg Capsules

Model:

D-0163-2018

Lot Numbers:

02022017@30

04172017@29

05082017@39

05222017@23

06072017@28

06122017@42

06192017@24

06292017@25

07112017@33

07172017@35

07282017@26

08012017@25

08112017@35

08142017@30

08172017@31

09202017@21

09142017@27

10022017@38

10102017@37

10172017@26

10202017@22

10302017@29

Date Ranges: 1/28/2018, 4/12/2018, 5/3/2018, 5/17/2018, 6/2/2018, 6/7/2018, 6/14/2018, 6/24/2018, 7/6/2018, 7/12/2018, 7/23/2018, 7/27/2018, 8/9/2018, 8/12/2018, 9/15/2018, 9/9/2018, 3/31/2018, 4/8/2018, 4/15/2018, 4/18/2018, 4/28/2018

Product: Arginine 150 mg/ Lysine HCl 50 mg/ Glutamine 200 mg/g Topical Cream

Model:

D-0164-2018

Lot Numbers:

05242017@54

Date Ranges: 11/20/2017

Product: Benzocaine 20%, Lidocaine 6%, Tetracaine 4% Cream

Model:

D-0165-2018

Lot Numbers:

06072017@22

06222017@30

08032017@31

09212017@21

10232017@20

Date Ranges: 12/4/2017, 12/19/2017, 1/30/2018, 3/20/2018, 11/22/2017

Product: Human Chorionic Gonadotropin (HCG) 11,000 iu/Vial Lyophilized

Model:

D-0177-2018

Lot Numbers:

06222017@10

09272017@14

05312017@5

07192017@8

Date Ranges: 12/19/2017, 3/26/2018, 11/27/2017, 1/15/2018

Product: Oxytocin 30 Units in 0.9% Sodium Chloride Solution (PF) IV Bag

Model:

D-0186-2018

Lot Numbers:

10112017@10

10252017@9

Date Ranges: 1/9/2018, 1/23/2018

Product: Vitamin 10 B Lyophilized Vial

Model:

D-0205-2018

Lot Numbers:

05232017@13

05262017@2

06022017@1

06092017@1

06162017@10

08142017@10

08252017@1

09222017@1

09292017@1

10062017@1

10132017@2

Date Ranges: 11/19/2017, 11/22/2017, 11/29/2017, 12/6/2017, 12/13/2017, 2/10/2018, 2/21/2018, 3/21/2018, 3/28/2018, 4/4/2018, 4/11/2018

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 78553

Status: Resolved

Manufacturer: KRS Global Biotechnology, Inc

Sold By: KRS Global Biotechnology, Inc; specialty pharmacies

Manufactured In: United States

Units Affected: 47 products (15,700 capsules; 80 vials; 22,520 capsules; 490 jars; 4,530 jars; 1,380 jars; 3,280 jars; 300 jars; 90 capsules; 20 jars; 100 jars; 300 jars; 2,239 tablets; 1,203 vials; 6,414 vials; 2,239 vials; 7,862 vials; 2,274 vials; 30 jars; 1,009 vials; 596 vials; 40 jars; 970 capsules; 696 vials; 2,535 vials; 963 bags; 3,000 tablets; 300 jars; 126 vials; 122 vials; 129 vials; 30 droptainers; 3,000 tablets; 80 cartridges; 597 vials; 157 vials; 898 vials; 235 vials; 94 vials; 173 vials; 297 droptainers; 81 droptainers; 479 vials; 3612 vials; 5786 vials; 90 capsules; 90 capsules)

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 packaging for the 'BUD' (Beyond Use Date) and Lot Number. Affected products include Anastrozole, Human Chorionic Gonadotropin (HCG), various 'QUADMIX' and 'Trimix' injections, and specialized creams and powders.

Identify if your product is included by matching the lot numbers and dates, such as Anastrozole 0.5 mg (Lot 03092017@21, BUD 3/9/2018), HCG 11,000 iu (Lot 06222017@10, BUD 12/19/2017), or Vitamin 10 B (Lot 05232017@13, BUD 11/19/2017).

Stop using any affected medication immediately if you identify a recalled lot number.

Contact your healthcare provider or pharmacist to discuss your treatment and determine if a replacement prescription is necessary.

Return any unused portion of the recalled medication to the pharmacy or place of purchase for a refund.

Contact KRS Global Biotechnology, Inc. at their distributor location in Boca Raton, Florida, for further instructions regarding this recall.

For additional questions or to report a complaint, contact the FDA Consumer Complaint hotline at 1-888-723-3332 or visit www.fda.gov/safety/recalls.

Affected Products

Product: Anastrozole 0.5 mg Capsules

Model:

D-0161-2018

Lot Numbers:

03092017@21

03292017@33

05092017@38

05162017@31

05182017@25

07032017@40

07142017@34

07192017@32

08282017@25

09142017@8

09212017@23

09272017@36

10162017@39

11032017@28

Date Ranges: 3/9/2018, 3/24/2018, 5/4/2018, 5/11/2018, 5/13/2018, 6/28/2018, 7/9/2018, 7/14/2018, 8/23/2018, 9/9/2018, 9/16/2018, 9/22/2018, 10/11/2018, 10/29/2018

Product: Amphotericin 60 mg/Chloramphenicol 600 mg/Hydrocortisone 10 mg Otic Powder

Model:

D-0162-2018

Lot Numbers:

07282017@25

Date Ranges: 1/24/2018

Product: Anastrozole SR 1 mg Capsules

Model:

D-0163-2018

Lot Numbers:

02022017@30

04172017@29

05082017@39

05222017@23

06072017@28

06122017@42

06192017@24

06292017@25

07112017@33

07172017@35

07282017@26

08012017@25

08112017@35

08142017@30

08172017@31

09202017@21

09142017@27

10022017@38

10102017@37

10172017@26

10202017@22

10302017@29

Product: Arginine 150 mg/ Lysine HCl 50 mg/ Glutamine 200 mg/g Topical Cream

Model:

D-0164-2018

Lot Numbers:

05242017@54

Date Ranges: 11/20/2017

Product: Benzocaine 20%, Lidocaine 6%, Tetracaine 4% Cream

Model:

D-0165-2018

Lot Numbers:

06072017@22

06222017@30

08032017@31

09212017@21

10232017@20

Date Ranges: 12/4/2017, 12/19/2017, 1/30/2018, 3/20/2018, 11/22/2017

Product: Human Chorionic Gonadotropin (HCG) 11,000 iu/Vial Lyophilized

Model:

D-0177-2018

Lot Numbers:

06222017@10

09272017@14

05312017@5

07192017@8

Date Ranges: 12/19/2017, 3/26/2018, 11/27/2017, 1/15/2018

Product: Oxytocin 30 Units in 0.9% Sodium Chloride Solution (PF) IV Bag

Model:

D-0186-2018

Lot Numbers:

10112017@10

10252017@9

Date Ranges: 1/9/2018, 1/23/2018

Product: Vitamin 10 B Lyophilized Vial

Model:

D-0205-2018

Lot Numbers:

05232017@13

05262017@2

06022017@1

06092017@1

06162017@10

08142017@10

08252017@1

09222017@1

09292017@1

10062017@1

10132017@2

Date Ranges: 11/19/2017, 11/22/2017, 11/29/2017, 12/6/2017, 12/13/2017, 2/10/2018, 2/21/2018, 3/21/2018, 3/28/2018, 4/4/2018, 4/11/2018

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 78553

Status: Resolved

Manufacturer: KRS Global Biotechnology, Inc

Sold By: KRS Global Biotechnology, Inc; specialty pharmacies

Manufactured In: United States

Distributed To: Nationwide