Manufacturer profile
B. Braun Medical Inc.
Pharmaceutical company4 products tracked
4
products tracked
93,586
total reports
32
recalls on record
88.6%
serious overall
Products
showing 4 of 4
| Product | Approved | Reports ↓ | Top signal | Recalls |
|---|---|---|---|---|
| 1975 | 50,632 | Peritoneal cloudy effluent | 19 | |
| 1996 | 15,696 | Encephalopathy | 0 | |
| 1983 | 15,483 | Anaphylactic shock | 8 | |
| 1973 | 11,775 | Anaphylactic shock | 5 |
Recall history · 22 on record
| Date | Class | Reason | Firm |
|---|---|---|---|
| Oct 2, 2023 | II | Lack of Assurance of Sterility | Pine Pharmaceuticals, LLC |
| Aug 2, 2023 | III | Labeling: Not Elsewhere Classified - the description, warnings, storage information and instructions for use are either missing or partially printed. | B. Braun Medical Inc. |
| Jul 5, 2023 | II | Lack of assurance of sterility: bags have the potential to leak. | B. Braun Medical Inc. |
| Feb 10, 2023 | II | Lack of sterility assurance: Recall of certain batches of 0.9% Sodium Chloride for Injection USP in EXCEL¿ Plus IV Container product due to the possibility of an incomplete seal that may cause leakage. The impacted lots may exhibit microscopic channel leaks near the port assembly of the product. | B. Braun Medical Inc. |
| Feb 10, 2023 | II | Lack of sterility assurance: Recall of certain batches of 0.9% Sodium Chloride for Injection USP in EXCEL¿ Plus IV Container product due to the possibility of an incomplete seal that may cause leakage. The impacted lots may exhibit microscopic channel leaks near the port assembly of the product. | B. Braun Medical Inc. |
| Oct 7, 2022 | II | Lack of Assurance of Sterility: FDA inspection found the recalled products were produced in a manner than cannot guarantee the sterility of the products purported to be sterile. | Pharmacy Plus, Inc. dba Vital Care Compounder |
| May 9, 2022 | II | Lack of assurance of sterility. | Olympia Compounding Pharmacy dba Olympia Pharmacy |
| Mar 7, 2022 | II | Lack of Assurance of Sterility | TMC Acquisition LLC dba Tailor Made Compounding |
| Dec 6, 2021 | II | Lack of Assurance of Sterility | Edge Pharma, LLC |
| Aug 13, 2021 | II | Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns | First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy |
| Jan 15, 2020 | II | Lack of Assurance of Sterility | Fusion IV Pharmaceuticals, Inc. dba Axia Pharmaceutical |
| Aug 12, 2019 | II | Lack of Assurance of Sterility | First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy |
| Jun 19, 2019 | II | Lack of Assurance of Sterility | RXQ Compounding LLC |
| Feb 19, 2019 | II | Incorrect Product Formulation; compounded sterile drug reconstituted using sterile water instead of sterile 0.9% Sodium Chloride. | Leiter's Enterprises, Inc. |
| Aug 23, 2018 | II | Presence of Particulate Matter: Particulate matter was reported in one lot of Cefuroxime by a physician after use of product.. FDA analysis identified the particulate as coring of the rubber stopper | Pacific Compounding Pharmacy & Consultations Inc |
| Jan 24, 2018 | III | Subpotent Drug: The product is sub-potent prior to its 90-day beyond use date. | JCB Laboratories LLC |
| Aug 15, 2017 | II | Lack of Assurance of Sterility. | Bella Pharmaceuticals, Inc. |
| Nov 18, 2016 | II | Lack of Assurance of Sterility - the firm is recalling select sterile drug products. | Cantrell Drug Company |
| Sep 20, 2016 | II | Lack of Assurance of Sterility; all compounded products within expiry produced using recalled filters | Leiter's Compounding |
| Oct 6, 2014 | II | Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection. | Oregon Compounding Centers, Inc. dba Creative Compounds |
| 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 31, 2013 | I | Non-Sterility: The firm's contract testing laboratory found sterility failures. | Abrams Royal Pharmacy |
Class I = reasonable probability of serious harm · Class II = temporary or reversible · Class III = unlikely to cause harm.
Registration status
Some products from B. Braun Medical 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.