Medications & Supplements/Prescription Drugs

American Health Packaging: Anastrozole Tablets Recalled Due to Potential Cross Contamination

Agency Publication Date: July 10, 2019

Summary

American Health Packaging is recalling 375,921 bottles of Anastrozole Tablets (1 mg), a prescription medication used to treat breast cancer. This recall was initiated because of a failure in cleaning procedures at the manufacturing facility, which could lead to cross-contamination between different drug products. The affected medication was distributed nationwide in 30-count and 1,000-count bottles under the BluePoint Laboratories label.

Risk

A failure in the manufacturer's cleaning process creates a risk that traces of other medications could contaminate these tablets. Ingesting a drug contaminated with an unintended active ingredient could cause unpredictable side effects or adverse reactions, especially for patients with specific allergies or sensitivities.

What You Should Do

Check your prescription bottle for the product name 'Anastrozole Tablets, USP, 1 mg' and the NDC numbers 68001-155-04 (30-count) or 68001-155-08 (1000-count).
If you have a 30-count bottle, check for lot numbers M711214, M711215, M711216, M711217 (Exp 8/31/2019); M802198, M802199 (Exp 1/31/2020); M805203, M805204, M805207 (Exp 3/31/2019); M812455 (Exp 6/30/2020); M815766 (Exp 9/30/2020); M818633, M818634 (Exp 10/31/2020); or M819858, M819859 (Exp 11/30/2020).
If you have a 1,000-count bottle, check for lot numbers M711218 (Exp 8/31/2019); M802197 (Exp 1/31/2020); M805209, M805946 (Exp 3/31/2020); M812456 (Exp 6/30/2020); M815767, M818273 (Exp 9/30/2020); or M819857 (Exp 11/30/2020).
Contact your healthcare provider or pharmacist immediately for guidance on whether you should continue taking your current supply or obtain a replacement.
Return any unused medication from the affected lots to the pharmacy where you purchased it for a refund.
For further instructions, contact American Health Packaging at their distribution facility or call the FDA Consumer Complaint line at 1-888-723-3332 (1-888-SAFEFDA).

Your Remedy Options

Full Refund

Healthcare provider consultation and pharmacy 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, USP, 1 mg (30-count bottle)

Model:

NDC 68001-155-04

Lot Numbers:

M711214 (Exp 8/31/2019)

M711215 (Exp 8/31/2019)

M711216 (Exp 8/31/2019)

M711217 (Exp 8/31/2019)

M802198 (Exp 1/31/2020)

M802199 (Exp 1/31/2020)

M805203 (Exp 3/31/2019)

M805204 (Exp 3/31/2019)

M805207 (Exp 3/31/2019)

M812455 (Exp 6/30/2020)

M815766 (Exp 9/30/2020)

M818633 (Exp 10/31/2020)

M818634 (Exp 10/31/2020)

M819858 (Exp 11/30/2020)

M819859 (Exp 11/30/2020)

Date Ranges: 8/31/2019, 1/31/2020, 3/31/2019, 6/30/2020, 9/30/2020, 10/31/2020, 11/30/2020

Product: Anastrozole Tablets, USP, 1 mg (1000-count bottle)

Model:

NDC 68001-155-08

Lot Numbers:

M711218 (Exp 8/31/2019)

M802197 (Exp 1/31/2020)

M805209 (Exp 3/31/2020)

M805946 (Exp 3/31/2020)

M812456 (Exp 6/30/2020)

M815767 (Exp 9/30/2020)

M818273 (Exp 9/30/2020)

M819857 (Exp 11/30/2020)

Date Ranges: 8/31/2019, 1/31/2020, 3/31/2020, 6/30/2020, 9/30/2020, 11/30/2020

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 83290

Status: Resolved

Manufacturer: American Health Packaging

Sold By: BluePoint Laboratories; pharmacies nationwide

Manufactured In: India

Units Affected: 375,921 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 prescription bottle for the product name 'Anastrozole Tablets, USP, 1 mg' and the NDC numbers 68001-155-04 (30-count) or 68001-155-08 (1000-count).

If you have a 30-count bottle, check for lot numbers M711214, M711215, M711216, M711217 (Exp 8/31/2019); M802198, M802199 (Exp 1/31/2020); M805203, M805204, M805207 (Exp 3/31/2019); M812455 (Exp 6/30/2020); M815766 (Exp 9/30/2020); M818633, M818634 (Exp 10/31/2020); or M819858, M819859 (Exp 11/30/2020).

If you have a 1,000-count bottle, check for lot numbers M711218 (Exp 8/31/2019); M802197 (Exp 1/31/2020); M805209, M805946 (Exp 3/31/2020); M812456 (Exp 6/30/2020); M815767, M818273 (Exp 9/30/2020); or M819857 (Exp 11/30/2020).

Contact your healthcare provider or pharmacist immediately for guidance on whether you should continue taking your current supply or obtain a replacement.

Return any unused medication from the affected lots to the pharmacy where you purchased it for a refund.

For further instructions, contact American Health Packaging at their distribution facility or call the FDA Consumer Complaint line at 1-888-723-3332 (1-888-SAFEFDA).

Affected Products

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

Model:

NDC 68001-155-04

Lot Numbers:

M711214 (Exp 8/31/2019)

M711215 (Exp 8/31/2019)

M711216 (Exp 8/31/2019)

M711217 (Exp 8/31/2019)

M802198 (Exp 1/31/2020)

M802199 (Exp 1/31/2020)

M805203 (Exp 3/31/2019)

M805204 (Exp 3/31/2019)

M805207 (Exp 3/31/2019)

M812455 (Exp 6/30/2020)

M815766 (Exp 9/30/2020)

M818633 (Exp 10/31/2020)

M818634 (Exp 10/31/2020)

M819858 (Exp 11/30/2020)

M819859 (Exp 11/30/2020)

Date Ranges: 8/31/2019, 1/31/2020, 3/31/2019, 6/30/2020, 9/30/2020, 10/31/2020, 11/30/2020

Product: Anastrozole Tablets, USP, 1 mg (1000-count bottle)

Model:

NDC 68001-155-08

Lot Numbers:

M711218 (Exp 8/31/2019)

M802197 (Exp 1/31/2020)

M805209 (Exp 3/31/2020)

M805946 (Exp 3/31/2020)

M812456 (Exp 6/30/2020)

M815767 (Exp 9/30/2020)

M818273 (Exp 9/30/2020)

M819857 (Exp 11/30/2020)

Date Ranges: 8/31/2019, 1/31/2020, 3/31/2020, 6/30/2020, 9/30/2020, 11/30/2020