Cefdinir for Oral Suspension USP, 250mg/5mL, packaged in a) 60mL (NDC 68180-723-20), b)100mL (NDC 68180-723-10), Rx Only, Manufactured for: Lupin Pharmaceuticals Inc. Baltimore, MD 21202; Manufactured by: Lupin Limited Mandideep 462 046 INDIA
Check against the official notice below — it lists the full affected range.
Lupin Pharmaceuticals Inc. is recalling Cefdinir for Oral Suspension USP 250mg/5mL in two package sizes nationwide. The recall affects 287,784 bottles across multiple lots with expiration dates ranging from January through April 2019. The company received complaints that the reconstituted suspension appeared thick, which indicates deviations from manufacturing standards.
The affected lots include specific batch numbers for both the 60mL bottles (NDC 68180-723-20) and 100mL bottles (NDC 68180-723-10). The source document does not specify a remedy or recommended action for consumers who have this product.
Written by software from the official notice below. Not reviewed by a lawyer.
CGMP Deviations: Product complaints received indicating reconstituted suspension was observed to be thick.
Reason for recall: CGMP Deviations: Product complaints received indicating reconstituted suspension was observed to be thick. Distribution: Nationwide within the United States Quantity: 287,784 bottles Lot/code info: a) Lot #: F700343, F700344, F700345, F700346, F700347,F700376, F700377, F700415, F700146,F700417, F700418, Exp. Jan 2019; F700419, F700420, F700492, F700493,F700508,F700665, Exp. February 2019; F700784, Exp. April 2019; b) Lot #: F700324, F700325, F700326, Exp. January 2019; F700618, F700619, F700620, Exp. February 2019.
Official record: FDA (Drug enforcement) ↗
Republished from the official source above; details can change — the source record controls.