American Health Packaging Recalls Anastrozole Tablets Due to GMP Deviations
American Health Packaging is recalling Anastrozole Tablets due to potential cross-contamination from cleaning procedure failures.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, and the source text does not report any illnesses or injuries, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
American Health Packaging is recalling Anastrozole Tablets, USP, 1 mg, in 30-count and 1000-count bottles. The recall affects 375,921 bottles distributed nationwide in the United States. The product is manufactured by Cadila Healthcare Ltd. for BluePoint Laboratories.
The recall was initiated due to Good Manufacturing Practice (GMP) deviations, specifically potential cross-contamination resulting from cleaning procedure failures. The affected lots include various expiration dates ranging from 2019 to 2020.
Consumers and healthcare providers should stop using the recalled product and contact their pharmacist or healthcare provider for guidance on replacement or refund options.
The recalled product
- Product
- ANASTROZOLE (ANASTROZOLE)
- Brand
- ANASTROZOLE
- Manufacturer
- American Health Packaging
- Category
- Drug — Prescription Drug
- Affected units
- 375,921
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- Count
- Lot
- Expiry: [30-count bottle] Lots M711214
- M711215
- M711216
- M711217
- exp 8/31/2019
- Lots M802198
- M802199
- exp 1/31/2020
- Lots M805203
- M805204
- M805207
- exp 3/31/2019
- Lots M812455
- exp 6/30/2020
- Lot M815766
- exp 9/30/2020
- Lots M818633
- M818634
UPCs (1)
- 0368001155045
Distribution
Distributed nationwide across the United States.
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