Aripiprazole Tablets, USP, 10 mg, 100 Tablets (10 x 10) unit dose blisters [NDC60687-179-11 recall — FDA D-0595-2018
CGMP Deviations: lot made with active pharmaceutical ingredient that did not meet all its intended specifications.
Overview of recall records associated with American Health Packaging, including dates, categories and classifications where available.
Classification mix: Class II: 35, Class III: 10, Class I: 2.
CGMP Deviations: lot made with active pharmaceutical ingredient that did not meet all its intended specifications.
Tablets/Capsules Imprinted with Wrong ID: Some tablets incorrectly imprinted with an X on one side.
CGMP Deviations: Firm did not adequately investigate customer complaints.
CGMP Deviations: Firm did not adequately investigate customer complaints.
CGMP Deviations: Firm did not adequately investigate customer complaints.
CGMP Deviations: Firm did not adequately investigate customer complaints.
CGMP Deviations: Firm did not adequately investigate customer complaints.
CGMP Deviations: Firm did not adequately investigate customer complaints.
CGMP Deviations: Firm did not adequately investigate customer complaints.
CGMP Deviations: Firm did not adequately investigate customer complaints.
CGMP Deviations: Firm did not adequately investigate customer complaints.
CGMP Deviations: Firm did not adequately investigate customer complaints.
CGMP Deviations: Firm did not adequately investigate customer complaints.
CGMP Deviations: Firm did not adequately investigate customer complaints.
CGMP Deviations: Firm did not adequately investigate customer complaints.
Failed USP Dissolution Test Requirements: This sub-recall is in response to Prometheus Laboratories Inc. recall for Mercaptopurine USP 50mg because the lot does not meet the specification…
Labeling: Label Mix-Up: Some cartons of AHP Ibuprofen Tablets, USP, 600mg, lot #142588 that contain blister cards filled with Ibuprofen tablets, 600mg drug product, were found to be…
Labeling: Label Mix-Up: Some cartons of AHP Ibuprofen Tablets, USP, 600mg, lot #142588 that contain blister cards filled with Ibuprofen tablets, 600mg drug product, were found to be…
Failed Stability Specifications; out of specification results at the 9 month stability time point for color, dissolution and related compounds.
Unit Dose Mispackaging: This recall event is due to a random undetected packaging issue which could increase the potential for a small number of individual unit dose blisters to be packed…
Failed Dissolution Test Requirements: During analysis of long term stability studies at 3 months time point, an OOS was reported for Quetiapine Fumarate Tablets, 25 mg.
Failed USP Dissolution Test Requirements: This sub-recall is in response to Prometheus Laboratories Inc. recall for Mercaptopurine USP 50mg because the lot does not meet the specification…
Labeling: Label Mix-Up: A typographical error in the product form on the carton label incorrectly lists the configuration as 30 "Capsules" (3 x 10) rather than "Tablets".
This page summarizes recall records in which the official source identifies American Health Packaging 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.