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.
Check against the official notice below — it lists the full affected range.
Teva Pharmaceuticals USA is recalling Cephalexin for Oral Suspension, USP 250 mg per 5 mL in both 100 mL and 200 mL bottles when mixed. The recall affects approximately 1.5 million bottles distributed nationwide in the U.S. and Puerto Rico due to manufacturing deviations that may have resulted in some bottles containing the active ingredient above or below specification limits. The affected bottles span multiple lot numbers with expiration dates ranging from August 2020 through November 2021.
The record does not specify what consumers should do regarding this recall or what remedy is available.
Written by software from the official notice below. Not reviewed by a lawyer.
CGMP deviations; there is a possibility that some bottles in these lots may have the active ingredient above and/or below specification limits.
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. Distribution: Nationwide in the U.S. and Puerto Rico. Quantity: 1,467,535 bottles 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.
Official record: FDA (Drug enforcement) ↗
Republished from the official source above; details can change — the source record controls.