Pacira Recalls Sub-Potent Exparel Bupivacaine Injectable Vials
Pacira Pharmaceuticals is recalling 910 vials of Exparel (Bupivacaine) because the drug was found to be sub-potent and out of specification.
What this means for you
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, which is a reasonable probability of temporary or medically reversible adverse health consequences. The hazard is a quality control issue (sub-potency) without reported injuries.
Plain-English summary
Pacira Pharmaceuticals, Inc. is recalling 910 20 mL vials of Exparel (Bupivacaine) Liposome Injectable Suspension, 1.3%. The product is identified by Pacira Lot # 19-5002 and Patheon manufacturer Lot # 098214, with an expiration date of December 2019.
The recall was initiated because the drug was found to be sub-potent and out of specification (OOS). This means the medication did not meet the required quality standards for potency.
The affected vials were distributed nationwide in the USA. Patients and healthcare providers should stop using the recalled product and contact their healthcare provider for further instructions.
The recalled product
- Product
- EXPAREL (BUPIVACAINE)
- Brand
- EXPAREL
- Manufacturer
- Pacira Pharmaceuticals, Inc.
- Category
- Drug — Injectable Anesthetic
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)
- Pacira Lot #: 19-5002
- Patheon manufacturer Lot #: 098214
- Exp. Date: Dec 2019
Distribution
Distributed nationwide across the United States.
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