Amerisource Health Services LLC recalls
20 recalls on record · 1 rated Critical · FDA
Every recall we have on record for Amerisource Health Services LLC, compiled from federal safety data. Check the hazard, the remedy, and how serious each one is, and always confirm on the official notice.
Oxycodone Hydrochloride Tablets, USP (CII), 5 mg, 100-Count (10 x 10) blister cards per…
Defective container: card seal defects (weak/non-existent seals), leading to the tablets falling out of their cavities.
Prazosin Hydrochloride, Capsules, USP, 5 mg, 20 capsules (5x4) cartons, Rx only,…
Failed Impurities/Degradation Specification: presence of N-nitroso Prazosin impurity C above the Carcinogenic Potency Categorization Approach (CPCA) acceptable intake limit
Sucralfate Tablets, USP 1 gram, 100 Tablets, (10x10), Rx Only, Distributed by: American…
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.
chlorproMAZINE Hydrochloride Tablets, USP, 200 mg, 100 (10x10) blisterpack per carton, Rx…
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 micro-organism was detected on any tablets.
chlorproMAZINE Hydrochloride Tablets, USP, 50 mg, 100 (10x10) blisterpacks, Rx Only,…
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 micro-organism was detected on any tablets.
Indomethacin Extended-Release Capsules, USP, 75 mg, 30 capsules (3 x 10 blister cards)…
cGMP deviations
Haloperidol Decanoate Injection, 100 mg/mL*, 1 x 1 mL Single-Dose Vial, Rx only,…
Lack of assurance of sterility. Bacterial contamination detected in some media fill units
Haloperidol Decanoate Injection, 100mg/mL*, 5 x 1 mL Single-Dose Vials, Rx Only, …
Lack of assurance of sterility. Bacterial contamination detected in some media fill units
glipiZIDE, Extended-Release Tablets, 2.5 mg, 30-count (3x10 blister cards) carton, Rx…
Failed Dissolution Specifications:
Clobazam Tablets, 10 mg, packaged in 30 tablets per carton (3x10 blister cards each), Rx…
Presence of Foreign Tablets/Capsules
Duloxetine Delayed-Release Capsules, USP, 30 mg, Rx only, 90 count bottles, Manufactured…
CGMP Deviations: Presence of N-nitroso-duloxetine impurity above the recommended interim limit.
Duloxetine Delayed-Release Capsules USP, 30 mg, Rx only, 30 count bottles, Manufactured…
CGMP Deviations: Presence of N-nitroso-duloxetine impurity above the recommended interim limit.
Duloxetine Delayed-Release Capsules, USP, 60 mg, Rx only, 1,000 count bottle,…
CGMP Deviations: Presence of N-nitroso-duloxetine impurity above the recommended interim limit
Duloxetine Delayed-Release Capsules, USP, 30 mg, Rx only, a) 30 count (NDC 68001-414-04)…
CGMP Deviations: Presence of N-nitroso-duloxetine impurity above the recommended interim limit
Potassium Chloride Extended-Release Capsules, USP, (750 mg) 10 mEq K, a).100-count bottle…
Failed Dissolution Specifications
buPROPion Hydrochloride Extended-release Tablets USP (XL) Once-Daily, 150 mg, 100 Tablets…
Failed Dissolution Specifications; the product is dissolving faster than the specified limits.
Febuxostat Tablets, 40 mg, 30 Tablets (3 x 10) per carton, Rx only, Distributed by:…
CGMP Deviations
Rifampin Capsules USP, 150 mg, 30 Capsules (3 x 10) unit doses per carton, Rx Only,…
Failed Impurities/Degradation Specification.
HydrALAZINE Hydrochloride Tablets, USP, 10 mg, 100 Tablets (10 x 10) per carton, Rx Only,…
Failed Impurities/Degradation Specifications: Out of Specification results in the repackaged product for impurities at the 12-month time point.
Glimepiride Tablets, USP, 4 mg, RX, Packaged as a) 100-count bottle, NDC# 68001-179-00;…
CGMP Deviations: recalling drug products following an FDA inspection.