Recalls / Class II
Class IID-0013-2021
Product
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.
- Brand name
- Cephalexin
- Generic name
- Cephalexin
- Active ingredient
- Cephalexin
- Route
- Oral
- NDCs
- 0093-3145, 0093-3147, 0093-4175, 0093-4177
- FDA application
- ANDA062702
- Affected lot / code info
- 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.
Why it was recalled
CGMP deviations; there is a possibility that some bottles in these lots may have the active ingredient above and/or below specification limits.
Recalling firm
- Firm
- Teva Pharmaceuticals USA
- Manufacturer
- Teva Pharmaceuticals USA, Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 400 Interpace Pkwy, Parsippany, New Jersey 07054-1120
Distribution
- Quantity
- 1,467,535 bottles
- Distribution pattern
- Nationwide in the U.S. and Puerto Rico.
Timeline
- Recall initiated
- 2020-08-24
- FDA classified
- 2020-10-02
- Posted by FDA
- 2020-09-16
- Terminated
- 2021-12-16
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0013-2021. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.