Amerisource Health Services LLC: Drug Recall

Recall Details

Recall Number

D-0100-2025

Classification

Class II

Product Type

Drug

Recalling Firm

Amerisource Health Services LLC

Status

Ongoing

Date Initiated

11/14/2024

Location

Columbus, OH, United States

Voluntary/Mandated

Voluntary: Firm initiated

Product Quantity

23,490 bottles

Reason for Recall

CGMP Deviations: Presence of N-nitroso-duloxetine impurity above the recommended interim limit

Product Description

Duloxetine Delayed-Release Capsules, USP, 30 mg, Rx only, a) 30 count (NDC 68001-414-04) and b) 1,000 count (NDC 68001-414-08) bottles, Manufactured by: Aurobindo Pharma Limited, Hyderabad-500 090, India, For BluePoint Laboratories

Distribution Pattern

PA, OH, PR

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 →