The Recall Desk
SevereFDA (Drugs)·D-1394-2019·Announced 2019-06-26

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
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.

Same brand · ANASTROZOLE