Manufacturer profile
BluePoint Laboratories
Pharmaceutical company4 products tracked
4
products tracked
122,013
total reports
13
recalls on record
79.9%
serious overall
Products
showing 4 of 4
| Product | Approved | Reports ↓ | Top signal | Recalls |
|---|---|---|---|---|
| 1983 | 73,031 | Febrile neutropenia | 5 | |
| 2006 | 36,591 | Pleural effusion | 1 | |
| 1979 | 7,461 | Vaginal flatulence | 4 | |
| 2006 | 4,930 | Acute myeloid leukaemia recurrent | 3 |
Recall history · 11 on record
| Date | Class | Reason | Firm |
|---|---|---|---|
| Jul 2, 2024 | II | CGMP Deviations: Out of Specification for Total Aerobic Microbial Count (TAMC) test for unfiltered bulk for decitabine for injection. | SUN PHARMACEUTICAL INDUSTRIES INC |
| Mar 15, 2021 | II | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Cardinal Health Inc. |
| Mar 15, 2021 | II | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Cardinal Health Inc. |
| Feb 10, 2021 | II | Lack 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 |
| Jun 12, 2019 | II | Lack of Assurance of Sterility | Infusion Options, Inc. |
| Jun 12, 2019 | II | Lack of Assurance of Sterility | Infusion Options, Inc. |
| Mar 5, 2018 | III | Failed impurities/degradation specifications: Failure to water content and impurity | InvaGen Pharmaceuticals, Inc. |
| Dec 22, 2016 | II | Failed dissolution specification: recalled due to an out of specification dissolution result of 40% (Specification: NLT 80%) | Sandoz Incorporated |
| Feb 12, 2015 | II | Lack of Assurance of Sterility and Stability Data does not Support Expiry: recent inspection observations associated with certain quality control procedures that present a risk to sterility and quality assurance. | Health Innovations Pharmacy, Inc |
| Nov 14, 2014 | II | Penicillin Cross Contamination: All lots of all products repackaged and distributed between 01/05/12 and 02/12/15 are being recalled because they were repackaged in a facility with penicillin products without adequate separation which could introduce the potential for cross contamination with penicillin. | Attix Pharmaceuticals |
| Nov 14, 2014 | II | Penicillin Cross Contamination: All lots of all products repackaged and distributed between 01/05/12 and 02/12/15 are being recalled because they were repackaged in a facility with penicillin products without adequate separation which could introduce the potential for cross contamination with penicillin. | Attix Pharmaceuticals |
Class I = reasonable probability of serious harm · Class II = temporary or reversible · Class III = unlikely to cause harm.
Registration status
Some products from BluePoint Laboratories 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.