Manufacturer profile
Bayer HealthCare Pharmaceuticals Inc.
Pharmaceutical company8 products tracked
8
products tracked
173,295
total reports
9
recalls on record
77.4%
serious overall
Products
showing 8 of 8
| Product | Approved | Reports ↓ | Top signal | Recalls |
|---|---|---|---|---|
| 2005 | 51,767 | Gallbladder injury | 6 | |
| — | 45,168 | Gallbladder injury | 3 | |
| 2013 | 31,875 | Pulmonary arterial hypertension | 0 | |
| 1993 | 19,028 | Multiple sclerosis | 0 | |
| 2012 | 11,442 | Colorectal cancer metastatic | 0 | |
| 2019 | 5,120 | Hormone-refractory prostate cancer | 0 | |
| 2013 | 4,976 | Hormone-refractory prostate cancer | 0 | |
| 1995 | 3,919 | Contrast encephalopathy | 0 |
Recall history · 16 on record
| Date | Class | Reason | Firm |
|---|---|---|---|
| Nov 19, 2021 | III | Subpotent Drug | Lupin Pharmaceuticals Inc. |
| Oct 1, 2021 | I | Chemical Contamination: presence of benzene | Bayer Healthcare Pharmaceuticals Inc. |
| Oct 1, 2021 | I | Chemical Contamination: presence of benzene | Bayer Healthcare Pharmaceuticals Inc. |
| Oct 1, 2021 | II | cGMP Deviations: manufactured at the same facility where other lots were found to be contaminated with benzene. | Bayer Healthcare Pharmaceuticals Inc. |
| Oct 1, 2021 | II | cGMP Deviations: manufactured at the same facility where other lots were found to be contaminated with benzene. | Bayer Healthcare Pharmaceuticals Inc. |
| Oct 1, 2021 | I | Chemical Contamination: presence of benzene | Bayer Healthcare Pharmaceuticals Inc. |
| Oct 1, 2021 | II | cGMP Deviations: manufactured at the same facility where other lots were found to be contaminated with benzene. | Bayer Healthcare Pharmaceuticals Inc. |
| Oct 1, 2021 | II | cGMP Deviations: manufactured at the same facility where other lots were found to be contaminated with benzene. | Bayer Healthcare Pharmaceuticals Inc. |
| Oct 1, 2021 | II | cGMP Deviations: manufactured at the same facility where other lots were found to be contaminated with benzene. | Bayer Healthcare Pharmaceuticals Inc. |
| Oct 1, 2021 | I | Chemical Contamination: presence of benzene | Bayer Healthcare Pharmaceuticals Inc. |
| Jul 9, 2019 | I | Failed dissolution specifications : failed results at the 3-month stability time point. | Jubilant Cadista Pharmaceuticals, Inc. |
| Mar 1, 2019 | II | Contraceptive Tablets Out of Sequence: Missing or incorrect tablet placement. | Apotex Inc. |
| Jun 13, 2013 | III | Failed Stability Specifications: Out of specification results for particle size were obtained at the 60 month test point. | Bayer HealthCare Pharmaceuticals Inc. |
| Feb 13, 2013 | II | Failed Tablet/Capsule Specification; tablet breakage while pushing through the blister pack (dispenser) . | Watson Laboratories Inc |
| Jan 22, 2013 | III | Tablet/Capsule Imprinted with Wrong ID; a portion of the tablets could contain the incorrect debossing on one side of the tablet U2 instead of U3. | Sandoz Incorporated |
| May 8, 2012 | II | Cross Contamination w/Other Products: This active pharmaceutical ingredient is being recalled due to cross contamination with another product. | Bayer HealthCare 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 Bayer HealthCare Pharmaceuticals Inc. 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.