May 2019 FDA Recall Anastrozole by American Health Packaging
D-1394-2019 - GMP Deviations
This Class II drug recall was voluntarily initiated by American Health Packaging on May 9, 2019 for the product Anastrozole. The FDA reported the reason for recall as gmp deviations. The product was distributed Nationwide and the recall is currently terminated.
Recall Number: D-1394-2019
GMP Deviations: Potential cross contamination due to cleaning procedure failure.
05-09-2019
06-26-2019
15,386 cartons
Recall Profile & Regulatory Data
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
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
American Health Packaging
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Nationwide within the USA
09-30-2020
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Anastrozole Tablets, USP, 1mg, 30-count unit dose blisters per carton, Rx Only, Packaged and Distributed by: American Health Packaging, Columbus, Ohio 43217. NDC 60687-112-21.
Batch or Lot Expiration Information
Lot# : 175289A, 175286B, 175290B, Exp. 08/31/2019; 179906A, Exp. 03/31/2020; 183252A, Exp. 09/30/2020; 184611A, Exp. 11/30/2020
