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Class III: unlikely to cause harmTerminated

Dr. Reddy's Laboratories Atorvastatin Calcium Tablets Recall

Atorvastatin Calcium Tablets, 40mg, packaged in a) 90-count bottles

Dr. Reddy's Laboratories, Inc. · Princeton, NJ

Risk level
Class III
Reported by FDA
Mar 10, 2021
Recall ID
D-0291-2021
Check your lot numberHow we source this data

Summary

Dr. Reddy's Laboratories recalled Atorvastatin Calcium Tablets starting Feb 19, 2021. The FDA classified it as Class III (unlikely to cause harm) and published enforcement report D-0291-2021 on Mar 10, 2021. Reason: Failed Impurities/Degradation Specifications:presence of ATV cyclo IP and FP, Dihydroxy epoxy and Dieto epoxy impurities. Status: Terminated.

Why it was recalled

Failed Impurities/Degradation Specifications:presence of ATV cyclo IP and FP, Dihydroxy epoxy and Dieto epoxy impurities

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

Lot numbers, UPCs & expiration codes

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

Where it was sold

Distributed Nationwide in the USA

What to do if you have this product

  • Compare the lot number and expiration date on your package with the codes above.
  • Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
  • If you have symptoms you think are related, contact your doctor. In an emergency call 911.
  • Report side effects to FDA MedWatch at 1-800-FDA-1088.

Recall details

Recall number
D-0291-2021
Classification
Class III
Status
Terminated
Recall initiated
Feb 19, 2021
FDA report date
Mar 10, 2021
Quantity
10,440 90-count and 224,710 500-count bottles
Recall type
Voluntary: Firm initiated
Recalling firm
Dr. Reddy's Laboratories, Inc.

Original FDA data

Every field from FDA enforcement report D-0291-2021, exactly as published.

Show all FDA fields
City
Princeton
State
NJ
Status
Terminated
Country
United States
Event ID
87365
Address
107 College Rd E
Code information
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
Postal code
08540-6623
Report date
Mar 10, 2021
Product type
Drugs
Recall number
D-0291-2021
Classification
Class III
Recalling firm
Dr. Reddy's Laboratories, Inc.
Product quantity
10,440 90-count and 224,710 500-count bottles
Termination date
Sep 7, 2023
Reason for recall
Failed Impurities/Degradation Specifications:presence of ATV cyclo IP and FP, Dihydroxy epoxy and Dieto epoxy impurities
Voluntary / mandated
Voluntary: Firm initiated
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
Distribution pattern
Distributed Nationwide in the USA
Recall initiation date
Feb 19, 2021
Initial firm notification
Letter
Center classification date
Mar 1, 2021

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-0291-2021, published Mar 10, 2021. View the source record (openFDA) · FDA enforcement reports

Last checked against FDA data: . Content last changed: .

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