Why it was recalled
Failed Dissolution Specifications; Low Out of specification (OOS) results for dissolution.
Product description
Tretinoin Capsules, 10 mg, 100 count bottle, Rx Only, Teva Pharmaceuticals USA, Inc., North Wales, PA 19454, NDC 0555-0808-02
Lot numbers, UPCs & expiration codes
Lot #: 100022970, Exp. 08/2022
Where it was sold
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-0520-2022
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Jan 10, 2022
- FDA report date
- Feb 9, 2022
- Quantity
- 1,175 Bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Teva Pharmaceuticals USA
Original FDA data
Every field from FDA enforcement report D-0520-2022, exactly as published.
Show all FDA fields
- City
- Parsippany
- State
- NJ
- Status
- Terminated
- Country
- United States
- Event ID
- 89385
- Address
- 400 Interpace Pkwy
- Code information
- Lot #: 100022970, Exp. 08/2022
- Postal code
- 07054-1120
- Report date
- Feb 9, 2022
- Product type
- Drugs
- Recall number
- D-0520-2022
- Classification
- Class II
- Recalling firm
- Teva Pharmaceuticals USA
- Product quantity
- 1,175 Bottles
- Termination date
- Dec 21, 2022
- 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, 100 count bottle, Rx Only, Teva Pharmaceuticals USA, Inc., North Wales, PA 19454, NDC 0555-0808-02
- Distribution pattern
- nationwide in the USA
- Recall initiation date
- Jan 10, 2022
- Initial firm notification
- Letter
- Center classification date
- Feb 2, 2022