Why it was recalled
Presence of foreign substance: Foreign matter has been identified as latex glove in one lot of Atorvastatin Calcium Tablets USP 40 mg.
Product description
Atorvastatin Calcium Tablets, USP 40 mg, Rx only, 500-count bottle, Manufactured by: Sun Pharmaceutical Industries Limited Mohali, INDIA, Distributed by: Sun Pharmaceutical Industries, Inc. Cranbury, NJ 08512, NDC 63304-829-05
Lot numbers, UPCs & expiration codes
Lot#: AA33617, Exp 03/2021
Where it was sold
U.S.A. Nationwide
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-1047-2020
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Mar 9, 2020
- FDA report date
- Mar 25, 2020
- Quantity
- 1416 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Sun Pharmaceutical Industries, Inc.
Original FDA data
Every field from FDA enforcement report D-1047-2020, exactly as published.
Show all FDA fields
- City
- Cranbury
- State
- NJ
- Status
- Terminated
- Country
- United States
- Event ID
- 85184
- Address
- 270 Prospect Plains Rd
- Code information
- Lot#: AA33617, Exp 03/2021
- Postal code
- 08512-3605
- Report date
- Mar 25, 2020
- Product type
- Drugs
- Recall number
- D-1047-2020
- Classification
- Class II
- Recalling firm
- Sun Pharmaceutical Industries, Inc.
- Product quantity
- 1416 bottles
- Termination date
- Feb 9, 2021
- Reason for recall
- Presence of foreign substance: Foreign matter has been identified as latex glove in one lot of Atorvastatin Calcium Tablets USP 40 mg.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Atorvastatin Calcium Tablets, USP 40 mg, Rx only, 500-count bottle, Manufactured by: Sun Pharmaceutical Industries Limited Mohali, INDIA, Distributed by: Sun Pharmaceutical Industries, Inc. Cranbury, NJ 08512, NDC 63304-829-05
- Distribution pattern
- U.S.A. Nationwide
- Recall initiation date
- Mar 9, 2020
- Initial firm notification
- Letter
- Center classification date
- Mar 19, 2020