The Recall Desk
SevereFDA (Drugs)·D-0097-2021·Announced 2020-11-25

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.

What this means for you

Illness, injury, or structural failure has been reported. 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
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.

Same manufacturer · Ascent Pharmaceuticals, Inc.

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