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FDA (Drug enforcement)Recalled 2019-05-09closedclass ii

American Health Packaging: Anastrozole Tablets, USP, 1 mg, a) 30-count (NDC 68001-155-04) and 1000-count (NDC 68001-155-08) bottles, Rx Only, Manufactured by: Cadila Healthcare Ltd., Ahmedabad, India

Is my product affected?

Anastrozole Tablets, USP, 1 mg, a) 30-count (NDC 68001-155-04) and 1000-count (NDC 68001-155-08) bottles, Rx Only, Manufactured by: Cadila Healthcare Ltd., Ahmedabad, India For BluePoint Laboratories

  • Brand ANASTROZOLE

Check against the official notice below — it lists the full affected range.

What happened

American Health Packaging is recalling Anastrozole Tablets, USP, 1 mg in both 30-count and 1000-count bottles due to potential cross contamination resulting from a cleaning procedure failure during manufacturing. The affected medication was distributed nationwide, with approximately 375,921 bottles involved. The recalled bottles span multiple lot numbers with expiration dates ranging from August 2019 through November 2020.

The recall affects specific lot numbers for both bottle sizes, which are identified in the distribution record. The source document does not specify what action affected consumers should take regarding this recall.

Written by software from the official notice below. Not reviewed by a lawyer.

Hazard

GMP Deviations: Potential cross contamination due to cleaning procedure failure.

Details from the source

Reason for recall: GMP Deviations: Potential cross contamination due to cleaning procedure failure. Distribution: Nationwide USA Quantity: 375,921 bottles Lot/code info: 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, exp 10/31/2020; Lots M819858, M819859, exp 11/30/2020 [1000-count bottle] Lot M711218, exp 8/31/2019; Lot M802197, exp 1/31/2020; Lots M805209, M805946, exp 3/31/2020; Lot M812456, exp 6/30/2020; Lots M815767, M818273, exp 9/30/2020; Lot M819857, exp 11/30/2020

Source

Official record: FDA (Drug enforcement) ↗

Republished from the official source above; details can change — the source record controls.

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