Lupin Recalls Cephalexin Oral Suspension Due to CGMP Deviations
Lupin Pharmaceuticals is recalling 14,400 bottles of Cephalexin for Oral Suspension due to CGMP deviations and the presence of extraneous material in sucrose excipients.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II, which corresponds to a Severe severity score under the rubric, as it involves a violation of CGMPs that could result in temporary or medically reversible health consequences.
Plain-English summary
Lupin Pharmaceuticals, Inc. is recalling 14,400 bottles of Cephalexin for Oral Suspension USP 250mg/5 mL. The affected product is identified by lot number F801282 and has an expiration date of June 2020. The product is a prescription-only medication manufactured for Lupin Pharmaceuticals, Inc. in Baltimore, Maryland, and manufactured by Lupin Limited in Mandideep, India.
The recall was initiated due to Current Good Manufacturing Practice (CGMP) deviations. Specifically, extraneous material was observed in the area between the primary heat-sealed package and the secondary packaging (poly-woven bag) of sucrose, an excipient used in the finished product.
The product was distributed to 5 wholesalers, 2 drug chains, and 1 supermarket, which may have further distributed the product throughout the United States. Consumers and healthcare providers should check their inventory for this specific lot number and expiration date. If found, the product should be returned to the pharmacy or point of purchase for a refund or replacement, or disposed of according to local regulations.
The recalled product
- Product
- CEPHALEXIN (CEPHALEXIN)
- Brand
- CEPHALEXIN
- Manufacturer
- Lupin Pharmaceuticals Inc.
- Category
- Drug — Antibiotic
- Affected units
- 14,400
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- lot F801282
- Expiry June 2020
Distribution
Distribution scope not specified by the agency.
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