Piramal Recalls Gablofen Baclofen Injection Due to Unknown Impurity
Piramal Critical Care is recalling Gablofen (baclofen injection) due to the presence of an unknown impurity observed during shelf life.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II and is initiated as a precaution due to an unknown impurity without reported illnesses or injuries, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Piramal Critical Care, Inc. is recalling Gablofen (baclofen injection), 50 mcg/mL, Single Use Syringe. The affected product is packaged in a box containing one 1 mL syringe and is distributed nationwide in the USA. The recall covers Lot 2155-111 (1,418 boxes) and Lot 2155-111A (5,640 boxes), with an expiration date of 6/20.
The recall is being initiated as a precaution due to the presence of an unknown impurity observed during the shelf life of the product. This is classified as an FDA Class II recall.
Healthcare providers and patients should stop using the affected lots of Gablofen. Consumers should contact their healthcare provider for guidance on alternative treatments or further instructions.
The recalled product
- Product
- GABLOFEN (BACLOFEN INJECTION)
- Brand
- GABLOFEN
- Manufacturer
- Piramal Critical Care, Inc.
- Category
- Drug — Prescription Injection
- Hazard
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (3)
- Lot #: 2155-111
- 2155-111A
- Exp 6/20
UPCs (3)
- 0366794157024
- 0366794155020
- 0366794156027
Distribution
Distributed nationwide across the United States.
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