Recall Enforment Report D-0291-2021

Drug Recall Enforcement Report Class III voluntary initiated by Dr. Reddy's Laboratories, Inc., originally initiated on 02-19-2021 for the product Atorvastatin Calcium Tablets, 40mg, packaged in a) 90-count bottles, NDC 55111-123-90; b) 500-count bottles, NDC 55111-123-05; Rx only, Mfd By: Dr. Reddy's Laboratories Limited Srikakulam - 532 409 INDIA The product was recalled due to failed impurities/degradation specifications:presence of atv cyclo ip and fp, dihydroxy epoxy and dieto epoxy impurities. The product was distributed nationwide and the recall is currently terminated.

Field Name	Field Value
Event ID	87365 What is the Event ID? A numerical designation assigned by FDA to a specific recall event (used for tracking purposes).
Recall Number	D-0291-2021 What is the Recall Number? An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes).
Recall Classification	Class III - is a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences. What is the Recall Classification? Numerical designation (I, II, or III) that is assigned by FDA to a particular product recall that indicates the relative degree of health hazard. For recalls pending classification, the entry will display as "Not Yet Classified".
Distribution Pattern	Distributed Nationwide in the USA What is the Distribution Pattern? General area of initial distribution such as states, countries, or territories. Note that subsequent distribution by the consignees to other parties may not be included.
Product Description	Atorvastatin Calcium Tablets, 40mg, packaged in a) 90-count bottles, NDC 55111-123-90; b) 500-count bottles, NDC 55111-123-05; Rx only, Mfd By: Dr. Reddy's Laboratories Limited Srikakulam - 532 409 INDIA
Reason For Recall	Failed Impurities/Degradation Specifications:presence of ATV cyclo IP and FP, Dihydroxy epoxy and Dieto epoxy impurities What is the Reason for Recall? Information describing how the product is defective.
Product Quantity	10,440 90-count and 224,710 500-count bottles Product Quantity The amount of product subject to recall.
Voluntary Mandated	Voluntary: Firm initiated Voluntary / Mandated Designates that a recall was initiated voluntarily by a firm on its own volition or after being requested to recall by FDA. “Mandatory” designates that a recall was initiated under a mandatory (statutory) recall authority, a court order, or FDA order.
Report Date	03-10-2021
Recall Initiation Date	02-19-2021 What is the Recall Initiation Date? The date that the firm first began notifying the public or their consignees of the recall.
Termination Date	09-07-2023 What is the Date Terminated? The date that FDA terminated the recall.
Initial Firm Notification	Letter Initial Firm Notification of Consignee or Public The method(s) by which the firm initially notified the public or their consignees of a recall.
Product Type	Drugs
Recalling Firm	Dr. Reddy's Laboratories, Inc.
Code Info	a) T900406, exp 3/2021 b) T000078 exp 12/2021 T000079 exp 12/2021 T000080 exp 12/2021 T000081 exp 12/2021 T000082 exp 12/2021 T000083 exp 12/2021 T000084 exp 12/2021 T000085 exp 12/2021 T000086 exp 12/2021 T000087 exp 12/2021 T000088 exp 1/2022 T000311 exp 1/2022 T000312 exp 1/2022 T000313 exp 1/2022 T000314 exp 1/2022 T000315 exp 1/2022 T000316 exp 1/2022 T000317 exp 1/2022 T000318 exp 1/2022 T000319 exp 1/2022 T000320 exp 1/2022 T000500 exp 2/2022 T000501 exp 2/2022 T000502 exp 2/2022 T000503 exp 2/2022 T000504 exp 2/2022 T000505 exp 2/2022 T000506 exp 2/2022 T000507 exp 2/2022 T000508 exp 2/2022 T000509 exp 3/2022 T000510 exp 3/2022 T000647 exp 3/2022 T000648 exp 3/2022 T000651exp 3/2022 T000652 exp 3/2022 T000653 exp 3/2022 T000654 exp 3/2022 T000875 exp 4/2022 T000876 exp 4/2022 T000877 exp 4/2022 T000878 exp 4/2022 T000879 exp 4/2022 T000880 exp 4/2022 T000881 exp 4/2022 T000882 exp 4/2022 T000883 exp 4/2022 T000884 exp 4/2022 T001120 exp 5/2022 T001121 exp 5/2022 T001122 exp 5/2022 T001124 exp 5/2022 T001125 exp 5/2022 T001126 exp 5/2022 T001127 exp 5/2022 T001128 exp 5/2022 T001129 exp 5/2022 T001130 exp 5/2022 T001260 exp 5/2022 T001261 exp 5/2022 T900506 exp 4/2021 T900507 exp 4/2021 T900508 exp 4/2021 T900655 exp 5/2021 T900656 exp 5/2021 T900657 exp 5/2021 T900658 exp 5/2021 T900659 exp 5/2021 T900673 exp 5/2021 T900674 exp 5/2021 T901024 exp 7/2021 T901025 exp 7/2021 T901026 exp 7/2021 T901027 exp 7/2021 T901029 exp 7/2021 T901030 exp 7/2021 T901031 exp 7/2021 T901032 exp 7/2021 T901033 exp 7/2021 T901424 exp 10/2021 T901425 exp 10/2021 T901426 exp 10/2021 T901427 exp 10/2021 T901428 exp 10/2021 T901429 exp 10/2021 T901430 exp 10/2021 T901431 exp 10/2021 T901432 exp 10/2021 T901433 exp 10/2021 T901568 exp 10/2021 T901569 exp 10/2021 T901570 exp 11/2021 T901571 exp 11/2021 T901572 exp 11/2021 T901573 exp 11/2021 T901574 exp 11/2021 T901575 exp 11/2021 T901576 exp 11/2021 T901577 exp 11/2021 Code Information A list of all lot and/or serial numbers, product numbers, expiration dates, sell or use by dates, etc., which appear on the product or its labeling.
Recalled NDC Packages	55111-121-30; 55111-121-60; 55111-121-90; 55111-121-05; 55111-121-10; 55111-122-30; 55111-122-60; 55111-122-90; 55111-122-05; 55111-122-10; 55111-123-30; 55111-123-60; 55111-123-90; 55111-123-05; 55111-123-10
Status	Terminated - A recall where FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.

Recalled Products