Cephalexin for Oral Suspension USP 250mg/5 mL, Rx Only Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore, Maryland, Manufactured by: Lupin Limited Mandideep 462 046 India --- NDC 68180-441-01
Check against the official notice below — it lists the full affected range.
Lupin Pharmaceuticals Inc. is recalling Cephalexin for Oral Suspension USP 250mg/5 mL due to the presence of extraneous material found between the primary heat-sealed package and secondary poly-woven bag of sucrose used in the finished product. This represents a deviation from current good manufacturing practice (CGMP). The recall involves 14,400 bottles from lot F801282 with an expiration date of June 2020.
The affected product was distributed to 5 wholesalers, 2 drug chains, and 1 supermarket, which may have further distributed it throughout the United States. The source document does not specify what actions consumers should take regarding this recall.
Written by software from the official notice below. Not reviewed by a lawyer.
CGMP Deviations; presence of extraneous material in the was observed in area that is between the primary package that is heat sealed and secondary packaging (poly-woven bag) of sucrose (an excipient) used in the finished product.
Reason for recall: CGMP Deviations; presence of extraneous material in the was observed in area that is between the primary package that is heat sealed and secondary packaging (poly-woven bag) of sucrose (an excipient) used in the finished product. Distribution: Product was distributed to 5 wholesalers, 2 drug chains and 1 supermarket who may have further distributed the product throughout the United States. Quantity: 14,400 bottles Lot/code info: lot F801282, Expiry June 2020
Official record: FDA (Drug enforcement) ↗
Republished from the official source above; details can change — the source record controls.