Ascend Recalls Cephalexin Oral Suspension Due to Unidentified Impurities
Ascend Laboratories is recalling Cephalexin for Oral Suspension because unidentified impurities were found in specific lots.
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 agency classified this as an FDA Class II recall. Per the rubric, FDA Class II recalls are assigned a severity score of 4 (Severe), particularly when involving significant quality deviations like impurities in prescription drugs.
Plain-English summary
Ascend Laboratories LLC is recalling Cephalexin for Oral Suspension, USP, 125 mg per 5 mL. The recall involves 20,232 bottles of the medication, which is distributed nationwide in the USA. The product is manufactured by Alkem Laboratories, Ltd, in Mumbai, India, and distributed by Ascend Laboratories, LLC, in Parsippany, NJ.
The recall was initiated because unidentified impurities not complying with specifications were observed in various lots of the product. The affected lots are 19144340 and 19144341 (expiration date AUG 2021) and 20142226 and 20142227 (expiration date MAY 2022). The product is available in 100 ml and 200 ml bottles.
Consumers and healthcare providers should check their inventory for these specific lot numbers and expiration dates. If the product matches the recalled lots, it should be discontinued and returned to the distributor or disposed of according to local regulations. Patients should consult their healthcare provider for alternative treatment options if necessary.
The recalled product
- Product
- CEPHALEXIN (CEPHALEXIN)
- Brand
- CEPHALEXIN
- Manufacturer
- Ascend Laboratories LLC
- Category
- Drug — Antibiotic
- Hazard
- Affected units
- 20,232
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 (6)
- Lot#: a) 19144340
- 19144341
- Exp AUG 2021
- b) 20142226
- 20142227
- Exp MAY 2022
Distribution
Distributed nationwide across the United States.
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