Ascent Pharmaceuticals Recalls Hydrocodone and Acetaminophen Tablets Due to Foreign Tablet
Ascent Pharmaceuticals is recalling 9,768 bottles of Hydrocodone Bitartrate and Acetaminophen Tablets because one bottle contained a Losartan Potassium tablet.
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, particularly given the risk of unintended medication exposure.
Plain-English summary
Ascent Pharmaceuticals, Inc. is recalling 9,768 bottles of Hydrocodone Bitartrate and Acetaminophen Tablets, USP 10 mg/325 mg, 100-count bottles. The recall is due to the presence of a foreign tablet; specifically, one bottle was found to contain one Losartan Potassium Tablet, USP 100 mg.
The affected product is identified by Lot # 20070518 and an expiration date of June 2022. The product was distributed nationwide within the United States. The tablets are manufactured by Ascent Pharmaceuticals, Inc. in Central Islip, NY, and manufactured for Camber Pharmaceuticals, Inc. in Piscataway, NJ.
Consumers should check their medication for the specific lot number and expiration date. If the product matches the description, consumers should stop using it and contact their healthcare provider or pharmacist for guidance on disposal or replacement.
The recalled product
- Product
- Hydrocodone Bitartrate and Acetaminophen Tablets, USP 10 mg/325mg 100-count bottles, Rx Only, Manufactured for : Camber Pharmaceuticals, Inc. Piscataway, NJ 08854, Manufactured by: Ascent Pharmaceuticals, Inc. Central Islip, NY 11722, NDC 31722-943-01
- Manufacturer
- Ascent Pharmaceuticals, Inc.
- Category
- Drug — Prescription Medication
- Affected units
- 9,768
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 #: 20070518
- Exp. Date June 2022
Distribution
Distributed nationwide across the United States.
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