Why it was recalled
Failed Dissolution Specifications; Low Out of Specification (OOS) results for dissolution.
Product description
Tretinoin Capsules, 10 mg, Rx Only, 100 capsules per bottle, Teva Pharmaceuticals USA Inc., North Wales, PA, 19454, NDC 0555-0808-02.
Lot numbers, UPCs & expiration codes
Lot #s: 100022971, Exp. 08/2022; 100022972, Exp. 05/2023; 100028920, Exp. 09/2023
Where it was sold
Nationwide in the U.S.
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-1156-2022
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Jun 14, 2022
- FDA report date
- Jun 29, 2022
- Quantity
- 4941 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Teva Pharmaceuticals USA Inc
Original FDA data
Every field from FDA enforcement report D-1156-2022, exactly as published.
Show all FDA fields
- City
- Parsippany
- State
- NJ
- Status
- Terminated
- Country
- United States
- Event ID
- 90430
- Address
- 400 Interpace Pkwy Bldg A
- Code information
- Lot #s: 100022971, Exp. 08/2022; 100022972, Exp. 05/2023; 100028920, Exp. 09/2023
- Postal code
- 07054-1120
- Report date
- Jun 29, 2022
- Product type
- Drugs
- Recall number
- D-1156-2022
- Classification
- Class II
- Recalling firm
- Teva Pharmaceuticals USA Inc
- Product quantity
- 4941 bottles
- Termination date
- Apr 27, 2023
- Reason for recall
- Failed Dissolution Specifications; Low Out of Specification (OOS) results for dissolution.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Tretinoin Capsules, 10 mg, Rx Only, 100 capsules per bottle, Teva Pharmaceuticals USA Inc., North Wales, PA, 19454, NDC 0555-0808-02.
- Distribution pattern
- Nationwide in the U.S.
- Recall initiation date
- Jun 14, 2022
- Initial firm notification
- Letter
- Center classification date
- Jun 23, 2022