Manufacturer profile
Blue Echo Care LLC
Pharmaceutical company2 products tracked
2
products tracked
1,439,995
total reports
14
recalls on record
18.2%
serious overall
Products
Recall history · 11 on record
| Date | Class | Reason | Firm |
|---|---|---|---|
| Apr 13, 2022 | II | cGMP deviations: Temperature abuse | Mckesson Medical-Surgical Inc. Corporate Office |
| Jan 26, 2022 | II | CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions. | CARDINAL HEALTHCARE |
| Nov 17, 2021 | I | Temperature Abuse; temperature excursion during shipping | Sandoz Inc |
| Mar 11, 2021 | II | Defective Delivery System: customer complaints concerning the injector pen breaking apart and disintegrating into pieces. | Ferring Pharmaceuticals Inc |
| Mar 11, 2021 | II | Defective Delivery System: customer complaints concerning the injector pen breaking apart and disintegrating into pieces. | Ferring Pharmaceuticals Inc |
| Feb 2, 2021 | I | Labeling; Label Mixup; syringe barrels may containing markings for 150 mg/mL (corresponding to 120 mg/0.8mL strength) instead of 100 mg/mL markings (corresponding to 100 mg/mL strength) | Apotex Corp. |
| Feb 2, 2021 | I | Labeling; Label Mixup; syringe barrels may contain markings for 100 mg/mL (corresponding to 100 mg/mL strength) instead of 150 mg/mL (corresponding to 120 mg/0.8mL strength) | Apotex Corp. |
| Jul 24, 2019 | II | Lack of Assurance of Sterility: product sterility cannot be guaranteed. | Colonia Care Pharmacy |
| Aug 14, 2018 | III | Defective Delivery System: Water ingress through the lower water cup sensor of the device. | United Therapeutics Corp. |
| Feb 12, 2016 | II | Lack of Assurance of Sterility | Walter's Pharmacy |
| May 21, 2012 | II | Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between 11/21/2011 and 05/21/2012. FDA environmental sampling revealed the presence of microorganisms and fungal growth in the clean room where sterile products were prepared. | Franck's Lab Inc., d.b.a. Franck's Compounding Lab |
Class I = reasonable probability of serious harm · Class II = temporary or reversible · Class III = unlikely to cause harm.
Registration status
Some products from Blue Echo Care 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.