Manufacturer profile
Baxter Healthcare Company
Pharmaceutical company3 products tracked
3
products tracked
197,972
total reports
34
recalls on record
96.3%
serious overall
Products
showing 3 of 3
| Product | Approved | Reports ↓ | Top signal | Recalls |
|---|---|---|---|---|
| — | 172,252 | Febrile neutropenia | 0 | |
| 1987 | 20,887 | Diffuse large b-cell lymphoma recurrent | 3 | |
| 1964 | 4,833 | Appendicolith | 31 |
Recall history · 24 on record
| Date | Class | Reason | Firm |
|---|---|---|---|
| Mar 8, 2022 | II | Super Potent and Failed Reconstitution Time | Olympia Compounding Pharmacy dba Olympia Pharmacy |
| Mar 8, 2022 | II | Product found to be Sub Potent or Exceeded reconstitution time | Olympia Compounding Pharmacy dba Olympia Pharmacy |
| Mar 8, 2022 | III | Sub Potent | Olympia Compounding Pharmacy dba Olympia Pharmacy |
| Mar 8, 2022 | II | Sub Potent | Olympia Compounding Pharmacy dba Olympia Pharmacy |
| Mar 8, 2022 | III | Super Potent | Olympia Compounding Pharmacy dba Olympia Pharmacy |
| Nov 20, 2020 | II | CGMP deviations: Lack of potency testing. | Complete Pharmacy and Medical Solutions, LLC. |
| Nov 20, 2020 | II | CGMP deviations: Lack of potency testing. | Complete Pharmacy and Medical Solutions, LLC. |
| Nov 20, 2020 | II | CGMP deviations: Lack of potency testing. | Complete Pharmacy and Medical Solutions, LLC. |
| Nov 20, 2020 | II | CGMP deviations: Lack of potency testing. | Complete Pharmacy and Medical Solutions, LLC. |
| Jun 12, 2019 | II | Lack of Assurance of Sterility | Infusion Options, Inc. |
| Sep 10, 2018 | II | Lack of Assurance of Sterility | Pharm D Solutions, LLC |
| Sep 10, 2018 | II | Lack of Assurance of Sterility | Pharm D Solutions, LLC |
| Sep 10, 2018 | II | Lack of Assurance of Sterility | Pharm D Solutions, LLC |
| Sep 10, 2018 | II | Lack of Assurance of Sterility | Pharm D Solutions, LLC |
| Sep 10, 2018 | II | Lack of Assurance of Sterility | Pharm D Solutions, LLC |
| Aug 15, 2017 | II | Lack of Assurance of Sterility. | Bella Pharmaceuticals, Inc. |
| Mar 8, 2016 | II | Chemical Contamination: Potential for contamination of the products with an aromatic hydrocarbon resin. | Hospira Inc. |
| Jun 2, 2015 | II | Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility | The Compounding Pharmacy of America |
| Aug 27, 2014 | II | Lack of Assurance of Sterility: Martin Avenue Pharmacy, Inc. is conducting a voluntary recall of all compounded sterile preparations within expiry. The recall is being initiated in connection with a recent FDA inspection due to observations associated with certain quality control procedures that present a risk to sterility assurance. | Martin Avenue Pharmacy, Inc. |
| Aug 27, 2014 | II | Lack of Assurance of Sterility: Martin Avenue Pharmacy, Inc. is conducting a voluntary recall of all compounded sterile preparations within expiry. The recall is being initiated in connection with a recent FDA inspection due to observations associated with certain quality control procedures that present a risk to sterility assurance. | Martin Avenue Pharmacy, Inc. |
| May 12, 2014 | II | Lack of Assurance of Sterility: Lack of sterility assurance in compounded aseptically filled injectable products. | John W Hollis Inc |
| Sep 13, 2013 | II | Temperature abuse: Certain vials of Ifosfamide IV products were not refrigerated at certain Amerisource Bergen Drug Corp distribution centers. | AmeriSource Bergen |
| Sep 13, 2013 | II | Temperature abuse: Certain vials of Ifosfamide IV products were not refrigerated at certain Amerisource Bergen Drug Corp distribution centers. | AmeriSource Bergen |
| May 28, 2013 | II | The firm received seven reports of adverse reactions in the form of skin abscesses potentially linked to compounded preservative-free methylprednisolone 80mg/ml 10 ml vials. | Main Street Family Pharmacy, LLC |
Class I = reasonable probability of serious harm · Class II = temporary or reversible · Class III = unlikely to cause harm.
Registration status
Some products from Baxter Healthcare Company 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.