CLASS II Drug recall · Reported 7 Aug 2019 · FDA Enforcement Report
Gablofen (baclofen injection), 50 mcg/mL, Single Use Syringe recalled
Piramal Critical Care is recalling Gablofen (baclofen injection), 50 mcg/mL, Single Use Syringe, distributed nationwide in the US. The recall was initiated on 8 Jul 2019 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-1742-2019
- FDA event ID
- 83280
- Recalling firm
- Piramal Critical Care, Bethlehem, PA
- Brand
- Gablofen
- Manufacturer
- Piramal Critical Care Inc
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 8 Jul 2019
- FDA classified
- 13 Aug 2019
- Reported
- 7 Aug 2019
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
- Drug class
- Injectable & IV Drugs
Timeline
| 8 Jul 2019 | Recall initiated by company | |
| 7 Aug 2019 | Published in enforcement report | +30 days |
| 13 Aug 2019 | Classified by FDA | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.
Product as listed by the FDA
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
Where it was distributed
USA Nationwide
Questions about this recall
Why was it recalled?
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.
Which lots are affected?
Lot #: 2155-111, 2155-111A, Exp 6/20
Where was it sold?
USA Nationwide
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Piramal Critical Care
All 3| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Rocuronium Bromide Injection 50mg/ Multi-Dose Vial recalled | Piramal Critical Care | Other | Nationwide |
| Drug | CLASS II | Sevoflurane, USP (Inhalation Anesthetic) recalledSevoflurane | Piramal Critical Care | Other | Nationwide |
Other Baclofen recalls
All 16| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Baclofen Tablets USP, 10 mg recalled by Golden State Medical SupplyBaclofen | Golden State Medical Supply | Other | Nationwide |
| Drug | CLASS II | Baclofen 2000MCG/ML INJ in syringe Assurance Infusion (713) recalled | Assurance Infusion | Sterility | Nationwide |
| Drug | CLASS II | Baclofen and Clonidine HCL and Morphine Sulfate recalled | Coast Quality Pharmacy | Packaging Defects | Nationwide |
| Drug | CLASS II | Baclofen 5000 mcg/ml, vol recalled by Hartley Medical Center | Hartley Medical Center Pharmacy | Sterility | Nationwide |
| Drug | CLASS II | Baclofen 2000 mcg/ml, vol recalled by Hartley Medical Center | Hartley Medical Center Pharmacy | Sterility | Nationwide |