Primidone Tablets, USP, 50 mg, 100 Tablets recall — FDA D-0537-2026
Cross contamination with other products: API contaminated with trace amounts of Acemetacin API.
Overview of recall records associated with Amerisource Health Services LLC, including dates, categories and classifications where available.
Classification mix: Class II: 15, Class III: 2.
Cross contamination with other products: API contaminated with trace amounts of Acemetacin API.
Cross contamination with other products: API contaminated with trace amounts of Acemetacin API.
Defective container: card seal defects (weak/non-existent seals), leading to the tablets falling out of their cavities.
Failed Impurities/Degradation Specification: presence of N-nitroso Prazosin impurity C above the Carcinogenic Potency Categorization Approach (CPCA) acceptable intake limit
Failed Impurities/Degradation Specification: presence of N-nitroso Prazosin impurity C above the Carcinogenic Potency Categorization Approach (CPCA) acceptable intake limit
Failed Impurities/Degradation Specification: presence of N-nitroso Prazosin impurity C above the Carcinogenic Potency Categorization Approach (CPCA) acceptable intake limit
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,…
Presence of a foreign substance.A specific lot of auxiliary polyester coil, used in product packaging at the manufacturing site, was detected with presence of a micro-organism. No…
Presence of a foreign substance.A specific lot of auxiliary polyester coil, used in product packaging at the manufacturing site, was detected with presence of a micro-organism. No…
Presence of a foreign substance.A specific lot of auxiliary polyester coil, used in product packaging at the manufacturing site, was detected with presence of a micro-organism. No…
Presence of a foreign substance.A specific lot of auxiliary polyester coil, used in product packaging at the manufacturing site, was detected with presence of a micro-organism. No…
CGMP Deviations: The recalling firm filed for Chapter 11 in September 2024. As a result, it cannot monitor the quality program and hence cannot assure that products meet the identity,…
Lack of assurance of sterility. Bacterial contamination detected in some media fill units
Lack of assurance of sterility. Bacterial contamination detected in some media fill units
Lack of assurance of sterility. Bacterial contamination detected in some media fill units
cGMP Deviations: Received notification from their supplier requesting they perform a recall due to the fact they repackaged the product.
CGMP Deviations: Presence of N-nitroso-duloxetine impurity above the recommended interim limit
This page summarizes recall records in which the official source identifies Amerisource Health Services LLC as the recalling firm or manufacturer. The number of records should not be treated as a safety rating or a measure of company size, because recall counts depend on product mix, reporting periods and how government records are organized.
Compare the dates, categories and classifications together rather than relying on the total alone. Open an individual record for the recalled product, reason, distribution details and current instructions available from the source.