Recalls / Class II
Class IID-0012-2021
Product
Cephalexin for Oral Suspension, USP 125 mg per 5 mL, For Reconstitution, For Oral Use Only, Rx Only, a) 100 mL bottle when mixed, NDC 0093-4175-73, b) 200 mL bottle when mixed, NDC 0093-4175-74, 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) 30309820A, Exp. 08/2020; 30310000B, 30310001B, Exp. 10/2020; 30310096A Exp. 01/2021; 30310228A, Exp. 03/2021; 30310313A, Exp. 06/2021; b) 30309861A, Exp. 08/2020; 30310335A, Exp. 06/2021.
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
- 103,940 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-0012-2021. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.