Cefdinir for Oral Suspension USP, 125mg/5mL, packaged in a) 60mL (NDC 68180-722-20), b)100mL (NDC 68180-722-10), 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, 125mg/5mL, in 60mL and 100mL bottles distributed nationwide in the United States. The recall affects 287,784 bottles across multiple lot numbers with expiration dates ranging from January 2019 to May 2019. The recall was initiated due to current Good Manufacturing Practice (CGMP) deviations, specifically because product complaints indicated that the reconstituted suspension was observed to be thick.
The source document does not specify a remedy or recommended action for consumers who have obtained 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 #: F700329, F700330, F700328, Exp. January 2019; F700544, F700545, F700668, F700669, F700670, Exp. March 2019; F700958, Exp. April 2019 b) Lot #: F700327, F700392, F700393, Exp. January 2019; F700546, F700547, F700664, Exp. March 2019; F700967, Exp. April 2019, F701106, F701107, F701108, F701109, Exp. May 2019.
Official record: FDA (Drug enforcement) ↗
Republished from the official source above; details can change — the source record controls.