Hydrocodone Bitartrate and Acetaminophen tablets recalled for product mix-up
Ascent Pharmaceuticals is recalling Hydrocodone Bitartrate and Acetaminophen 10 mg/325 mg tablets nationwide due to a product mix-up. The recall affects 9,744 bottles and was voluntarily initiated by the manufacturer.
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 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The source classifies this as FDA Class II. The recall is voluntary and precautionary due to a product mix-up with no reported illnesses or injuries stated in the source text. Class II recalls with no reported harm typically fall into the Moderate category.
Plain-English summary
Ascent Pharmaceuticals, Inc. is recalling Hydrocodone Bitartrate and Acetaminophen Tablets, USP 10 mg/325 mg in 100-count bottles manufactured for Camber Pharmaceuticals, Inc. The recall was initiated on November 19, 2021, and is classified as FDA Class II. The affected lot is #21070817 with an expiration date of June 2023, distributed nationwide across the United States.
The reason for the recall is a product mix-up. A total of 9,744 bottles have been affected. This is a voluntary recall initiated by the firm through letter notification to customers.
Consumers who have this medication should contact their healthcare provider or pharmacist for guidance. The recall was terminated on December 6, 2023.
The recalled product
- Product
- HYDROCODONE BITARTRATE AND ACETAMINOPHEN (HYDROCODONE BITARTRATE AND ACETAMINOPHEN)
- Brand
- HYDROCODONE BITARTRATE AND ACETAMINOPHEN
- Manufacturer
- Ascent Pharmaceuticals, Inc.
- Affected units
- 9,744
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 #: 21070817
- Exp 6/2023
UPCs (2)
- 0331722997010
- 0331722996013
Distribution
Distributed nationwide across the United States.
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