amerisource health services llc
8 recalls on record
A
Amerisource Health Services LLC — glipiZIDE, Extended-Release Tablets, 2.5 mg, 30-count (3x10 blister cards) carton, Rx Only, Distributed by: American Health Packaging, Columbus, Ohio 43217, Carton ND
Failed Dissolution Specifications:
FDAHealth
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Amerisource Health Services LLC — Duloxetine Delayed-Release Capsules, USP, 30 mg, Rx only, 90 count bottles, Manufactured by: Aurobindo Pharma Limited, Hyderabad-500 090, India, For BluePoint Laborat
CGMP Deviations: Presence of N-nitroso-duloxetine impurity above the recommended interim limit.
FDAHealth
A
Amerisource Health Services LLC — Duloxetine Delayed-Release Capsules USP, 30 mg, Rx only, 30 count bottles, Manufactured by: Aurobindo Pharma Limited, Hyderabad-500 090, India, For BluePoint Laborato
CGMP Deviations: Presence of N-nitroso-duloxetine impurity above the recommended interim limit.
FDAHealth
A
Amerisource Health Services LLC — Duloxetine Delayed-Release Capsules USP, 60 mg, Rx only, 30 count bottles, Manufactured by: Aurobindo Pharma Limited, Hyderabad-500 090, India, For BluePoint Laborato
CGMP Deviations: Presence of N-nitroso-duloxetine impurity above the recommended interim limit.
FDAHealth
A
Amerisource Health Services LLC — Duloxetine Delayed-Release Capsules, USP, 60 mg, Rx only, 1,000 count bottles, Manufactured by: Aurobindo Pharma Limited, Hyderabad-500 090, India, For BluePoint Labo
CGMP Deviations: Presence of N-nitroso-duloxetine impurity above the recommended interim limit.
FDAHealth
A
Amerisource Health Services LLC — Duloxetine Delayed-Release Capsules, USP, 20 mg, Rx only, 60 count bottles, Manufactured by: Aurobindo Pharma Limited, Hyderabad-500 090, India, For BluePoint Laborat
CGMP Deviations: Presence of N-nitroso-duloxetine impurity above the recommended interim limit
FDAHealth
A
Amerisource Health Services LLC — 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 Pha
CGMP Deviations: Presence of N-nitroso-duloxetine impurity above the recommended interim limit
FDAHealth
A
Amerisource Health Services LLC — Duloxetine Delayed-Release Capsules, USP, 60 mg, Rx only, 1,000 count bottle, Manufactured by: Aurobindo Pharma Limited, Hyderabad-500 090, India, For BluePoint Labor
CGMP Deviations: Presence of N-nitroso-duloxetine impurity above the recommended interim limit
FDAHealth