Failed Dissolution Specifications: Nitrofurantoin Capsules recalled due to dissolution failure at 0-time of the repackaged lot. Drug release results were above specification at 0-time.
AMERICAN HEALTH PACKAGING
Subpotent Drug: Out of specification for assay.
Impurity failure at 0-time of the repackaged lot.
Class I - Dangerous
Failed Dissolution Specifications
Failed Dissolution Specifications: results were above specification.
CGMP Deviations: Potential concern with products manufactured using liquid sugar batches contaminated with microbial organisms.
Class I - Dangerous
Failed Impurities/Degradation Specifications
Failed Dissolution Specifications
Labeling Not Elsewhere Classified: The statement Pharmacist: Dispense with the accompanying Medication Guide was not included on the carton label.
Failed dissolution specification - dissolution results of 59% (spec. NLT 85%) at the 24 month time point (end of shelf life).
CGMP Deviations: Potential N-Nitrosodimethylamine (NDMA) amounts above levels established by the FDA.
GMP Deviations: Product bottle may be absent of desiccant.
GMP Deviations: Product bottle may be absent of desiccant.
Failed Dissolution Specifications: Low out of specification results obtained during stability testing.
CGMP Deviations: Presence of NDMA impurity detected in product.
Labeling: Incorrect or Missing Package Insert; an error in the Dosage Forms and Strengths section of the insert that incorrectly lists the tablet description coding for the tablets.
Failed Impurities/Degradation Specifications; out of specification result for an unknown impurity in stability samples.
Failed Dissolution Specifications
CGMP Deviations: Finished product made with lovastatin drug substance that was out of specification for individual impurity results.
Failed Dissolution Specifications: Out of specification result for the dissolution test.
GMP Deviations: Potential cross contamination due to cleaning procedure failure.
GMP Deviations; possible cross contamination of product due to cleaning procedure failure.
GMP Deviations; possible cross contamination of product due to cleaning procedure failure.
GMP Deviations; possible cross contamination of product due to cleaning procedure failure.
GMP Deviations; possible cross contamination of product due to cleaning procedure failure.
Class I - Dangerous
GMP Deviations: Potential cross contamination due to cleaning procedure failure.
Class I - Dangerous
Failed Dissolution Specifications: dissolution failure at time zero of the repackaged lot. Drug release results were slightly above specification at time zero.
CGMP Deviation: Presence of NDEA (N-Nitrosodimethylamine), a carcinogen impurity, detected in the active ingredient.
Cross contamination with other products: This sub-recall is being initiated in support of the recall by the manufacturer (Sandoz) dated 11/1/18, which included lots that were repackaged by American Health Packaging. Sandoz stated that "These lots are being recalled due to the potential presence of unrelated ingredients (i.e. traces of active ingredients of Benazepril, Haloperidol and Perphenazine), which were identified through a manufacturing investigation."
Failed Impurities/Degradation Specification; out-of-specification results for the Enalapril DKT degradant
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 dissolution specifications
Failed Tablet/Capsule Specifications; recall initiated by manufacturer due to reports of wet capsules
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 for dissolution.
Subpotent; 6 month stability time point
Class I - Dangerous
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 mis-labeled with blister card print identifying the product as AHP Oxcarbazepine Tablets, 300mg, lot #142544
Class I - Dangerous
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 mis-labeled with blister card print identifying the product as AHP Oxcarbazepine Tablets, 300mg, lot #142544.
Class I - Dangerous
Good Manufacturing Practices Deviations: The product has an active pharmaceutical ingredient from an unapproved source.
Class I - Dangerous
Good Manufacturing Practices Deviations: The product has an active pharmaceutical ingredient from an unapproved source.
Class I - Dangerous
Subpotent
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 with more than one tablet.
Class I - Dangerous
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 for dissolution.
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".