August 2018 FDA Recall Atorvastatin Calcium by Dr. Reddy's Laboratories, Inc.
D-1079-2018 - Failed Impurities/Degradation Specifications - OOS was observed for ATV Cyclo FP Impurity and Total Degradation Impurities tested at the 18 month stability time point in Atorvastatin Calcium Tablets 40 mg 500 tablets.
This Class III drug recall was voluntarily initiated by Dr. Reddy's Laboratories, Inc. on August 2, 2018 for the product Atorvastatin Calcium. The FDA reported the reason for recall as failed impurities/degradation specifications - oos was observed for atv cyclo fp impurity and total degradation impurities tested at the 18 month stability time point in atorvastatin calcium tablets 40 mg 500 tablets.. The product was distributed Nationwide and the recall is currently terminated.
Recall Number: D-1079-2018
Failed Impurities/Degradation Specifications - OOS was observed for ATV Cyclo FP Impurity and Total Degradation Impurities tested at the 18 month stability time point in Atorvastatin Calcium Tablets 40 mg 500 tablets.
08-02-2018
08-22-2018
2280 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.
Dr. Reddy's Laboratories, 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.
U.S.A. Nationwide
04-15-2020
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Atorvastatin Calcium tablets, 40 mg, 500-count bottle, Rx only, Mfd By: Dr. Reddy's Laboratories Limited, Srikakulam - 532 409 India, NDC 55111-123-05
Batch or Lot Expiration Information
Lot# T60045
