American Health Packaging Recalls Anastrozole Tablets Due to Cleaning Failures
American Health Packaging is recalling 15,386 cartons of 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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The FDA classified this recall as Class II. According to the severity rubric, an FDA Class II recall is assigned a score of 4 (Severe), particularly when associated with significant potential hazards like cross-contamination.
Plain-English summary
American Health Packaging is recalling 15,386 cartons of Anastrozole Tablets, USP, 1mg, 30-count unit dose blisters. The product is distributed nationwide within the USA. The recall is being conducted due to Good Manufacturing Practice (GMP) deviations, specifically potential cross-contamination resulting from cleaning procedure failures.
The affected lots are 175289A, 175286B, and 175290B (Exp. 08/31/2019), 179906A (Exp. 03/31/2020), 183252A (Exp. 09/30/2020), and 184611A (Exp. 11/30/2020). The NDC for the recalled product is 60687-112-21.
Consumers and healthcare providers should stop using the recalled product and contact their pharmacist or healthcare provider for a replacement or refund. The FDA has classified this recall as Class II, indicating a situation in which use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.
The recalled product
- Product
- ANASTROZOLE (ANASTROZOLE)
- Brand
- ANASTROZOLE
- Manufacturer
- American Health Packaging
- Category
- Drug — Prescription Drug
- Affected units
- 15,386
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 (10)
- Lot #: 175289A
- 175286B
- 175290B
- Exp. 08/31/2019
- 179906A
- Exp. 03/31/2020
- 183252A
- Exp. 09/30/2020
- 184611A
- Exp. 11/30/2020
Distribution
Distributed nationwide across the United States.
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