PlainRecalls
FDA Drug Moderate Class II Terminated

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.

Reported: September 16, 2020 Initiated: August 24, 2020 #D-1566-2020

Product Description

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.

Reason for Recall

Sub-Potent Drug: Out of specification test results for potency (below specification).

Details

Recalling Firm
Teva Pharmaceuticals USA
Units Affected
38,487 bottles
Distribution
Nationwide in the U.S. and Puerto Rico.
Location
Parsippany, NJ

Frequently Asked Questions

What product was recalled?
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.. Recalled by Teva Pharmaceuticals USA. Units affected: 38,487 bottles.
Why was this product recalled?
Sub-Potent Drug: Out of specification test results for potency (below specification).
Which agency issued this recall?
This recall was issued by the FDA Drug on September 16, 2020. Severity: Moderate. Recall number: D-1566-2020.