Gablofen — Class II drug recall D-1742-2019
Terminated recall by Piramal Critical Care, Inc., reported 2019-08-07, distributed nationwide. Failed Impurities/Degradation Specification -This recall is being initiated as a precaution due to the presenc
| Recall number | D-1742-2019 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Piramal Critical Care, Inc., Bethlehem, PA, United States |
| Recall initiated | 2019-07-08 |
| Classified | 2019-08-13 |
| Reported by FDA | 2019-08-07 |
| Terminated | 2021-03-09 |
| Distributed | Nationwide (US) |
| Reason classes | specification failure |
| NDC | 66794-0151, 66794-0151-01, 66794-0155, 66794-0155-01, 66794-0155-02, 66794-0156, 66794-0156-01, 66794-0156-02, 66794-0157, 66794-0157-01, 66794-0157-02 |
| Lot numbers | 2155-111, 2155-111A, 6/20 |
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 for recall
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-1742-2019. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.