Tretinoin Capsules, 10 mg, Rx Only, 100 capsules per bottle, Teva Pharmaceuticals USA Inc., North Wales, PA, 19454, NDC 0555-0808-02.
Class I - DangerousWhat Should You Do?
- Check if you have this product: Lot #s: 100022971, Exp. 08/2022; 100022972, Exp. 05/2023; 100028920, Exp. 09/2023
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- Report problems: Report any issues to the FDA's Safety Reporting Portal.
⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.
Recall Details
- Company:
- Teva Pharmaceuticals USA Inc
- Reason for Recall:
- Failed Dissolution Specifications; Low Out of Specification (OOS) results for dissolution.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full Description:
Tretinoin Capsules, 10 mg, Rx Only, 100 capsules per bottle, Teva Pharmaceuticals USA Inc., North Wales, PA, 19454, NDC 0555-0808-02.
Product Codes/Lot Numbers:
Lot #s: 100022971, Exp. 08/2022; 100022972, Exp. 05/2023; 100028920, Exp. 09/2023
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: D-1156-2022
Related Recalls
Lack of Assurance of Sterility: Quality system deficiencies identified during a routine U.S Food and Drug Administration (FDA) inspection at the contract manufacturer.
Failed Impurities/Degradation Specifications: Out of specification for specific impurity Tretinoin
CGMP Deviations: use of an unapproved raw material