Recalls / Class II
Class IID-1566-2020
Product
Cephalexin for Oral Suspension, USP 250 mg per 5 mL, For Reconstitution, For Oral Use Only, Rx Only, 100 mL bottle when mixed, Teva Pharmaceuticals USA, Inc., North Wales, PA 19454, NDC 0093-4177-73.
- 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 #: 30310638A, Exp. 02/2022
Why it was recalled
Sub-Potent Drug: Out of specification test results for potency (below specification).
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
- 38,487 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-1566-2020. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.