Manufacturer profile
Amneal Pharmaceuticals NY LLC
Pharmaceutical company4 products tracked
4
products tracked
82,223
total reports
16
recalls on record
64.7%
serious overall
Products
showing 4 of 4
| Product | Approved | Reports ↓ | Top signal | Recalls |
|---|---|---|---|---|
| — | 43,079 | Device adhesion issue | 15 | |
| 2008 | 22,647 | Platelet count increased | 1 | |
| — | 9,456 | Methaemoglobinaemia | 0 | |
| 1997 | 7,041 | Migraine | 0 |
Recall history · 12 on record
| Date | Class | Reason | Firm |
|---|---|---|---|
| May 16, 2024 | III | Failed Impurities/Degradation Specifications. | Zydus Pharmaceuticals (USA) Inc |
| Feb 21, 2023 | III | Failed Content Uniformity Specifications: The Spray Content Uniformity (SCU) requirement for Standard Deviation did not meet the requirement at the 18-month stability time point. | Padagis US LLC |
| Apr 16, 2021 | II | Defective Delivery System: Out of specification for release rate testing and shear, an attribute related to the adhesive properties of the transdermal patches. As a result, patients could experience patches that do not stick well to the skin. | Noven Pharmaceuticals Inc |
| Mar 15, 2021 | II | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Cardinal Health Inc. |
| May 11, 2019 | I | Cross Contamination with Other Products: product is being recalled due to possible cross-contamination with peanut flour. | Novartis Pharmaceuticals Corp. |
| Sep 7, 2018 | II | Defective Delivery System: out of specification results for shear, an attribute related to the adhesive properties of the transdermal patches. | Noven Pharmaceuticals, Inc. |
| Sep 7, 2018 | II | Defective Delivery System: out of specification results for shear, an attribute related to the adhesive properties of the transdermal patches. | Noven Pharmaceuticals, Inc. |
| May 4, 2018 | II | Defective Delivery System: no longer meets the specification for shear, an attribute related to the adhesive properties of the transdermal patches. As a result, patients could experience patches that do not stick well to the skin. | Noven Pharmaceuticals, Inc. |
| May 4, 2018 | II | Defective Delivery System: no longer meets the specification for shear, an attribute related to the adhesive properties of the transdermal patches. As a result, patients could experience patches that do not stick well to the skin. | Noven Pharmaceuticals, Inc. |
| Feb 26, 2018 | II | Defective Delivery System: Potential that cracks in the vial neck near the crimp may result in product evaporation and/or leaking and the inability to properly dispense product. | Paddock Laboratories, LLC. |
| Apr 27, 2017 | III | Defective Delivery System: Out of specification for peel force from the release liner specification during stability testing at 18M 25C/60%RH. | Noven Pharmaceuticals, Inc. |
| Feb 25, 2015 | II | Temperature Abuse: Prolonged exposure to temperatures outside of labeled storage conditions. | Noven 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 Amneal Pharmaceuticals NY LLC 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.