Why it was recalled
Presence of Foreign Tablets/Capsules: a single tablet of Pravastatin 40 mg found in bottle of Atorvastatin Calcium 40 mg.
Product description
Atorvastatin Calcium Tablets, USP 40 mg*, 1,000 count bottles, Rx Only, Manufactured by: Apotex Inc. Toronto, Ontario Canada M9L 1T9 Manufactured for: Apotex Corp. Weston, Florida 33326 NDC 60505-2580-8
Lot numbers, UPCs & expiration codes
Lot: RC5439 Exp. 03/2022
Where it was sold
IL, MS, NJ, OH, TX
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-0153-2020
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- Oct 22, 2019
- FDA report date
- Nov 6, 2019
- Quantity
- 1968 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Apotex Inc.
Original FDA data
Every field from FDA enforcement report D-0153-2020, exactly as published.
Show all FDA fields
- City
- North York
- Status
- Terminated
- Country
- Canada
- Event ID
- 84107
- Address
- 150 Signet Drive
- Code information
- Lot: RC5439 Exp. 03/2022
- Report date
- Nov 6, 2019
- Product type
- Drugs
- Recall number
- D-0153-2020
- Classification
- Class III
- Recalling firm
- Apotex Inc.
- Product quantity
- 1968 bottles
- Termination date
- Feb 19, 2026
- Reason for recall
- Presence of Foreign Tablets/Capsules: a single tablet of Pravastatin 40 mg found in bottle of Atorvastatin Calcium 40 mg.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Atorvastatin Calcium Tablets, USP 40 mg*, 1,000 count bottles, Rx Only, Manufactured by: Apotex Inc. Toronto, Ontario Canada M9L 1T9 Manufactured for: Apotex Corp. Weston, Florida 33326 NDC 60505-2580-8
- Distribution pattern
- IL, MS, NJ, OH, TX
- Recall initiation date
- Oct 22, 2019
- Initial firm notification
- Letter
- Center classification date
- Oct 28, 2019