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.
What this means for you
Illness, injury, or structural failure has been reported. 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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