Cephalexin for Oral Suspension, USP 250 mg per 5 mL, For Reconstitution, For Oral Use Only, Rx Only, a) 100 mL bottle when mixed, NDC 0093-4177-73, b) 200 mL bottle when mixed, NDC 0093-4177-74, Teva Pharmaceuticals USA, Inc., North Wales, PA 19454.
Class I - DangerousWhat Should You Do?
- Check if you have this product: Lot #s: a) 30309862A, 30309863A, Exp. 08/2020; 30309928A, 30309929A, Exp. 09/2020; 30310029A, 30310030A, 30310033A, 30310034A, Exp. 10/2020; 30310035A, 30310079A, 30310080A, 30310081A, Exp. 11/2020; 30310134A, 30310135A, Exp. 01/2021; 30310182A, 30310183A, 30310210A, Exp. 02/2021; 30310211A, 30310246A, Exp. 03/2021; 30310282A, Exp. 04/2021; 30310290A, Exp. 05/2021; 30310394A, 30310395A, Exp.07/2021; 30310457A, Exp. 09/2021; 30310506A, 30310507A, Exp. 10/2021; 30310555A, 30310605A, Exp. 11/2021. b) 30309864A, 30309865A, Exp. 08/2020; 30309930A, 30309931A, Exp. 09/2020; 30309991A, 30309992A, 30310028A, Exp.10/2020; 30310036A, 30310037A, 30310038A, Exp. 11/2020; 30310082A, 30310083A, Exp. 12/2020; 30310136A, 30310137A, Exp. 01/2021; 30310184A, 30310185A, Exp. 02/2021; 30310212A, Exp. 03/2021; 30310303A, Exp. 04/2021; 30310327A, Exp. 06/2021; 30310396A, 30310407A, Exp. 08/2021; 30310445A, Exp. 09/2021; 30310556A, Exp. 10/2021.
- 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
- Reason for Recall:
- CGMP deviations; there is a possibility that some bottles in these lots may have the active ingredient above and/or below specification limits.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full Description:
Cephalexin for Oral Suspension, USP 250 mg per 5 mL, For Reconstitution, For Oral Use Only, Rx Only, a) 100 mL bottle when mixed, NDC 0093-4177-73, b) 200 mL bottle when mixed, NDC 0093-4177-74, Teva Pharmaceuticals USA, Inc., North Wales, PA 19454.
Product Codes/Lot Numbers:
Lot #s: a) 30309862A, 30309863A, Exp. 08/2020; 30309928A, 30309929A, Exp. 09/2020; 30310029A, 30310030A, 30310033A, 30310034A, Exp. 10/2020; 30310035A, 30310079A, 30310080A, 30310081A, Exp. 11/2020; 30310134A, 30310135A, Exp. 01/2021; 30310182A, 30310183A, 30310210A, Exp. 02/2021; 30310211A, 30310246A, Exp. 03/2021; 30310282A, Exp. 04/2021; 30310290A, Exp. 05/2021; 30310394A, 30310395A, Exp.07/2021; 30310457A, Exp. 09/2021; 30310506A, 30310507A, Exp. 10/2021; 30310555A, 30310605A, Exp. 11/2021. b) 30309864A, 30309865A, Exp. 08/2020; 30309930A, 30309931A, Exp. 09/2020; 30309991A, 30309992A, 30310028A, Exp.10/2020; 30310036A, 30310037A, 30310038A, Exp. 11/2020; 30310082A, 30310083A, Exp. 12/2020; 30310136A, 30310137A, Exp. 01/2021; 30310184A, 30310185A, Exp. 02/2021; 30310212A, Exp. 03/2021; 30310303A, Exp. 04/2021; 30310327A, Exp. 06/2021; 30310396A, 30310407A, Exp. 08/2021; 30310445A, Exp. 09/2021; 30310556A, Exp. 10/2021.
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: D-0013-2021
Related Recalls
Defective Container - A defect in the side-seal which allows leakage of product.
Subpotent drug; Clavulanate Potassium component
Prazosin Hydrochloride, Capsules, USP, 2 mg, Rx only, Distributed by TEVA PHARMACEUTICALS USA, INC., North Wales, PA 19454, a) 100 Capsules, NDC 0093-4068-01, b) 1000 Capsules, NDC 0093-4068-10
Teva Pharmaceuticals USA
CGMP Deviations-Test results for N-nitroso Prazosin impurity C that are above the Carcinogenic Potency Categorization Approach (CPCA) acceptable intake limit for the above specified lots.