Amerisource Health Services LLC: Drug Recall

Recall Details

Recall Number

D-0257-2024

Classification

Class III

Product Type

Drug

Recalling Firm

Amerisource Health Services LLC

Status

Ongoing

Date Initiated

12/26/2023

Location

Columbus, OH, United States

Voluntary/Mandated

Voluntary: Firm initiated

Product Quantity

6,344 cartons

Reason for Recall

Superpotent drug: Assay results were slightly above specification at the time zero point.

Product Description

Benzonatate Capsules, USP, 100 mg, 100 Capsules (10 capsules x 10 unit dose cards), Rx only, Distributed by: American Health Packaging, Columbus, Ohio 43217. Carton NDC 68084-214-01; Individual Dose NDC 68084-214-11

Distribution Pattern

Nationwide in the USA

Other Recalls by Amerisource Health Services LLC

• Class II: Risk 10/16/2025
  Failed Impurities/Degradation Specification: presence of N-nitroso Prazosin impurity C above the Carcinogenic Potency Categorization Approach (CPCA) acceptable intake limit
• Class II: Risk 10/16/2025
  Failed Impurities/Degradation Specification: presence of N-nitroso Prazosin impurity C above the Carcinogenic Potency Categorization Approach (CPCA) acceptable intake limit
• Class II: Risk 10/16/2025
  Failed Impurities/Degradation Specification: presence of N-nitroso Prazosin impurity C above the Carcinogenic Potency Categorization Approach (CPCA) acceptable intake limit
• Class II: Risk 10/09/2025
  CGMP Deviations: The recalling firm filed for Chapter 11 on September 30, 2024. As a result, it cannot monitor the quality program and hence cannot assure that products meet the identity, strength, quality, and purity characteristics that they are purported or represented to possess, rendering the products adulterated.
• Class II: Risk 09/15/2025
  Failed Dissolution Specifications.

View all recalls by Amerisource Health Services LLC →