July 2019 FDA Recall Drug by Aurobindo Pharma Usa Inc.
D-1842-2019 - Labeling; Incorrect or Missing Lot and/or Exp Date; some bottles labeled with lot number 05318054B instead of 05318034B
This Class III drug recall was voluntarily initiated by Aurobindo Pharma Usa Inc. on July 29, 2019 for the product Drug. The FDA reported the reason for recall as labeling; incorrect or missing lot and/or exp date; some bottles labeled with lot number 05318054b instead of 05318034b. The product was distributed Nationwide and the recall is currently terminated.
Recall Number: D-1842-2019
Labeling; Incorrect or Missing Lot and/or Exp Date; some bottles labeled with lot number 05318054B instead of 05318034B
07-29-2019
09-04-2019
2,352/1000 count 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.
Aurobindo Pharma USA 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.
Product was distributed nationwide by three major distributors who may have further distributed the product.
10-28-2021
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Simvastatin Tablets, USP 40 mg. Rx Only 1000 Count Bottles Manufactured by: Aurolife Pharma LLC Dayton NJ 08810 Manufactured for: Aurobindo Pharma USA, Inc. Dayton, NJ 08810 NDC 65862-053-99
Batch or Lot Expiration Information
Lot# 05318054B, exp 3/2021
