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Manufacturer profile

American Health Packaging

Pharmaceutical company9 products tracked
9
products tracked
305,146
total reports
58
recalls on record
81.2%
serious overall
Products
showing 9 of 9
ProductApprovedReports ↓Top signalRecalls
196888,112Colitis ulcerative2
198075,807Tardive dyskinesia12
199538,413Hypoglycaemia21
—31,032Kidney transplant rejection3
196520,833Sedation complication0
—19,587Recalled product0
199815,829Viral mutation identified2
200912,295Thrombosis in device3
19783,238Hypernatraemia15
Recall history · 50 on record
DateClassReasonFirm
May 23, 2025IIPresence of foreign tablets/capsules.Teva Pharmaceuticals USA, Inc
Mar 5, 2025IIFailed Dissolution SpecificationsGolden State Medical Supply Inc.
Feb 25, 2025IIFailed Dissolution Specifications - low dissolution resultsMYLAN PHARMACEUTICALS INC
Sep 3, 2024IIFailed Dissolution SpecificationsAscend Laboratories, LLC
Jan 18, 2024IIIMisprint on tabletDr. Reddy's Laboratories, Inc.
Jan 18, 2024IIIMisprint on tabletDr. Reddy's Laboratories, Inc.
Apr 6, 2023IICGMP deviations.PD-Rx Pharmaceuticals, Inc.
Mar 23, 2023IIcGMP Deviations for the manufacturing Firm (Accord Healthcare) after their inspection.Preferred Pharmaceuticals, Inc.
Mar 23, 2023IIcGMP Deviations for the manufacturing Firm (Accord Healthcare) after their inspection.Preferred Pharmaceuticals, Inc.
Mar 20, 2023IIcGMP DeviationsRemedyRepack Inc.
Mar 17, 2023IICGMP Deviations: recalling drug products following an FDA inspection.Amerisource Health Services LLC
Mar 17, 2023IICGMP Deviations: recalling drug products following an FDA inspection.Amerisource Health Services LLC
Mar 17, 2023IICGMP Deviations: recalling drug products following an FDA inspection.Amerisource Health Services LLC
Mar 16, 2023IICGMP DeviationsNorthwind Pharmaceuticals LLC
Mar 16, 2023IICGMP DeviationsNorthwind Pharmaceuticals LLC
Mar 13, 2023IIcGMP deviationsDirect Rx
Mar 13, 2023IIcGMP deviationsDirect Rx
Mar 13, 2023IIcGMP deviationsDirect Rx
Feb 7, 2023IICGMP Deviations: recalling drug products following an FDA inspection.Accord Healthcare, Inc.
Feb 7, 2023IICGMP Deviations: recalling drug products following an FDA inspection.Accord Healthcare, Inc.
Feb 7, 2023IICGMP Deviations: recalling drug products following an FDA inspection.Accord Healthcare, Inc.
Dec 5, 2022IISubpotent Drug: repackaged product was recalled by the manufacturer for subpotency.RemedyRepack Inc.
Nov 23, 2022IISubpotent DrugHeritage Pharmaceuticals Inc
Jun 29, 2022IICGMP DeviationsGlenmark Pharmaceuticals Inc., USA
May 3, 2022IIIFailed 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
Apr 12, 2022IIISubpotent Drug: Out of specification for assay.American Health Packaging
Feb 22, 2022IIImpurity failure at 0-time of the repackaged lot.American Health Packaging
Dec 20, 2021IIFailed Dissolution SpecificationsAmerican Health Packaging
Sep 17, 2021IIFailed Dissolution Specifications: results were above specification.American Health Packaging
Jul 29, 2021IILack of Assurance of SterilityTeva Pharmaceuticals USA
May 12, 2021IIIFailed Impurities/Degradation SpecificationsAmerican Health Packaging
Apr 26, 2021IILack of Assurance of SterilityTeva Pharmaceuticals USA
Mar 15, 2021IICGMP Deviations: Intermittent exposure to temperature excursion during storage.Cardinal Health Inc.
Feb 15, 2021IIChemical contamination; Unknown brown residue adhering to the inside of one vial.Teva Pharmaceuticals USA
Feb 10, 2021IILack of Assurance of Sterility: manufacturing areas for the recalled products exceeded acceptance levels for microbial recovery leading to a lack of sterility assurance for these sterile injectable products.Teva Pharmaceuticals USA
Feb 10, 2021IILack of Assurance of Sterility: manufacturing areas for the recalled products exceeded acceptance levels for microbial recovery leading to a lack of sterility assurance for these sterile injectable products.Teva Pharmaceuticals USA
Jan 7, 2021IIFailed Dissolution SpecificationsAmerican Health Packaging
Jul 21, 2020ISuperpotent DrugFerring Pharmaceuticals Inc
Jul 21, 2020ISuperpotent DrugFerring Pharmaceuticals Inc
Jul 21, 2020ISuperpotent DrugFerring Pharmaceuticals Inc
Jun 10, 2020IIILabeling Not Elsewhere Classified: The statement Pharmacist: Dispense with the accompanying Medication Guide was not included on the carton label.American Health Packaging
May 19, 2020IIFailed dissolution specification - dissolution results of 59% (spec. NLT 85%) at the 24 month time point (end of shelf life).American Health Packaging
Feb 7, 2020IIGMP Deviations: Product bottle may be absent of desiccant.American Health Packaging
Feb 7, 2020IIGMP Deviations: Product bottle may be absent of desiccant.American Health Packaging
Jan 27, 2020IIGMP Deviations: Product bottle may be absent of desiccant.Teva Pharmaceuticals USA
Jan 27, 2020IIGMP Deviations: Product bottle may be absent of desiccant.Teva Pharmaceuticals USA
Dec 4, 2019IIFailed Dissolution Specifications: Low out of specification results obtained during stability testing.American Health Packaging
Nov 20, 2019IICGMP Deviations: Potential N-Nitrosodimethylamine (NDMA) amounts above levels established by the FDA.American Health Packaging
Nov 1, 2019IICGMP Deviations: Presence of NDMA impurity detected in product.American Health Packaging
Oct 18, 2019IIFailed Dissolution Specification: Low out of specification dissolution results.Mylan Pharmaceuticals Inc.

Class I = reasonable probability of serious harm · Class II = temporary or reversible · Class III = unlikely to cause harm.

Registration status

Some products from American Health Packaging are not FDA-registered for human use. For unregistered substances (peptides, SARMs without human registration), no legitimate human-use supplier exists. The absence of a sourcing route is the safety information.