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.
Check against the official notice below — it lists the full affected range.
Teva Pharmaceuticals USA is recalling Cephalexin for Oral Suspension, USP 125 mg per 5 mL in 100 mL and 200 mL bottles due to manufacturing deviations. Some bottles in the affected lots may contain the active ingredient at levels above or below the specified amount. The recall affects approximately 103,940 bottles distributed nationwide in the U.S. and Puerto Rico across multiple lot numbers with expiration dates ranging from August 2020 to June 2021.
The source does not specify what action affected consumers should take in response to this recall.
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: 103,940 bottles 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.
Official record: FDA (Drug enforcement) ↗
Republished from the official source above; details can change — the source record controls.