July 2017 FDA Recall Pravastatin Sodium by Dr. Reddy's Laboratories, Inc.
D-1038-2017 - Failed Impurities/Degradation Specifications
This Class III drug recall was voluntarily initiated by Dr. Reddy's Laboratories, Inc. on July 11, 2017 for the product Pravastatin Sodium. The FDA reported the reason for recall as failed impurities/degradation specifications. The product was distributed Nationwide and the recall is currently terminated.
Recall Number: D-1038-2017
Failed Impurities/Degradation Specifications: high out of specification results for related impurity for lot C700220.
07-11-2017
08-09-2017
544 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.
Nationwide in the USA
04-01-2019
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Pravastatin Sodium Tablets, USP, 10 mg, packaged in a) 90-count bottles (NDC 55111-229-90) and b) 500-count bottles (NDC 55111-229-05), Rx only, Manufactured by: Dr. Reddy's Laboratories Limited, Bachupally - 500 090 INDIA; Distributed by: Dr. Reddy's Laboratories Inc., Princeton, NJ 08540 USA.
Batch or Lot Expiration Information
Lot# : a) C700220, Exp 06/18; b) C700220, Exp 06/18
