FDA Drug recall D-1742-2019
Gablofen (baclofen injection), 50 mcg/mL, Single Use Syringe, Rx only, packaged in a box containing one 1 mL syringe, Distributed by: Prima…
- FDA Drug
- Class II
- terminated
- Published 2019-08-07
On 2019-08-07 the FDA classified a Class II recall of Gablofen (baclofen injection), 50 mcg/mL, Single Use Syringe, Rx only, packaged in a box containing one 1 mL syringe, Distributed by: Prima… by Piramal Critical Care, citing failed Impurities/Degradation Specification -This recall is being initiated as a precaution due to the presence of an unknown impurity observed during shelf life of the product.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-1742-2019 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2019-07-08 |
| Published | 2019-08-07 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Piramal Critical Care |
| Distribution | US |
Product
Gablofen (baclofen injection), 50 mcg/mL, Single Use Syringe, Rx only, packaged in a box containing one 1 mL syringe, Distributed by: Primal Critical Care, Inc., 3950 Schelden Circle Bethlehem, PA, 18017, NDC 66794-151-01
Reason
Failed Impurities/Degradation Specification -This recall is being initiated as a precaution due to the presence of an unknown impurity observed during shelf life of the product.
Identifiers
| ndc | 66794-151-01 |
|---|---|
| ndc | 66794-155-01 |
| ndc | 66794-155-02 |
| ndc | 66794-156-01 |
| ndc | 66794-156-02 |
| ndc | 66794-157-01 |
| ndc | 66794-157-02 |
| code_info | Lot #: 2155-111, 2155-111A, Exp 6/20 |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1742-2019%22
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