Multi-event January 2018 FDA Recall Atorvastatin Calcium by Dr. Reddy's Laboratories, Inc.
This Multi-event Class III drug recall was voluntarily initiated by Dr. Reddy's Laboratories, Inc. on January 29, 2018 for the product Atorvastatin Calcium. The FDA reported the reason for recall as failed impurities/degradations specifications; out-of-specification results observed for total degradation impurities during stability. The product was distributed Nationwide and the recall is currently terminated.
Reported Recall Events
Recall Number: D-0418-2018
Failed Impurities/Degradations Specifications; out-of-specification results observed for Total Degradation Impurities during stability
01-29-2018
02-07-2018
a) 34,125; b) 3,540 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
12-07-2018
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Atorvastatin Calcium Tablets 10 mg, a) 90 count and b) 500 count bottles, Rx only, Mfd by: Dr. Reddy's Laboratories, Ltd., Srikakulam, INDIA --- NDC 55111-121-05
Batch or Lot Expiration Information
Lot# Lot numbers: a) T600125, 3/2018; T600201, T600248 5/2018, b) T600125, 3/2018; T600201, and T600248, 5/2018
Affected Packages Involved in this Recall
Recall Number: D-0419-2018
Failed Impurities/Degradations Specifications; out-of-specification results observed for Total Degradation Impurities during stability
01-29-2018
02-07-2018
a) 28,941 and b) 2,928 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
12-07-2018
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Atorvastatin Calcium Tablets 20 mg, a) 90 count and b) 500 count bottles, Rx only, Mfd by: Dr. Reddy's Laboratories, Ltd., Srikakulam, INDIA --- NDC 55111-122-05
Batch or Lot Expiration Information
Lot# Lot numbers: a) T600126, 3/2018; T600202 and T600247 5/2018, b) T600126, 3/2018; T600202, and T600247, 5/2018
Affected Packages Involved in this Recall
Recall Number: D-0420-2018
Failed Impurities/Degradations Specifications; out-of-specification results observed for Total Degradation Impurities during stability
01-29-2018
02-07-2018
12,579 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
12-07-2018
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Atorvastatin Calcium Tablets 40 mg, 90 count bottles, Rx only, Mfd by: Dr. Reddy's Laboratories, Ltd., Srikakulam, INDIA --- NDC 55111-123-05
Batch or Lot Expiration Information
Lot# Lot number: T600279, 6/2018
