October 2019 FDA Recall Atorvastatin Calcium by Apotex Inc.
D-0153-2020 - Presence of Foreign Tablets/Capsules
This Class III drug recall was voluntarily initiated by Apotex Inc. on October 22, 2019 for the product Atorvastatin Calcium. The FDA reported the reason for recall as presence of foreign tablets/capsules. The product was distributed in IL, MS, NJ, OH, TX and the recall is currently terminated.
Recall Number: D-0153-2020
Presence of Foreign Tablets/Capsules: a single tablet of Pravastatin 40 mg found in bottle of Atorvastatin Calcium 40 mg.
10-22-2019
11-06-2019
1968 bottles
Recall Profile & Regulatory Data
Class III - is a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.
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.
Apotex Inc.
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.
IL, MS, NJ, OH, TX
02-19-2026
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Atorvastatin Calcium Tablets, USP 40 mg*, 1,000 count bottles, Rx Only, Manufactured by: Apotex Inc. Toronto, Ontario Canada M9L 1T9 Manufactured for: Apotex Corp. Weston, Florida 33326 NDC 60505-2580-8
Batch or Lot Expiration Information
Lot# Lot: RC5439 Exp. 03/2022
