Pacira Recalls Subpotent EXPAREL Bupivacaine Injectable Vials
Pacira Pharmaceuticals is recalling 324 vials of EXPAREL (bupivacaine liposome injectable suspension) because the product is subpotent.
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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II, which corresponds to a Severe severity score under the rubric for significant injury or property damage reports or high-risk scenarios.
Plain-English summary
Pacira Pharmaceuticals, Inc. is recalling 324 vials of EXPAREL (bupivacaine liposome injectable suspension), 1.3%, 266 mg/20 mL (13.3 mg/mL). The recall is being conducted because the product is subpotent, meaning it contains less of the active ingredient than labeled.
The affected product is Lot #11-2005, Control #23542, with a manufacture date of 05Dec11. The vials are labeled for investigational use and infiltration only. The product was distributed nationwide to Arizona, the District of Columbia, Florida, Georgia, Massachusetts, New Jersey, New York, Ohio, and Texas.
Healthcare providers and patients should stop using the affected vials and contact Pacira Pharmaceuticals for further instructions.
The recalled product
- Product
- EXPAREL (bupivacaine liposome injectable suspension), 1.3%, 266 mg/20 mL (13.3 mg/mL) single use vials, INVESTIGATIONAL USE. For Infiltration Only. Not for any other route of administration. Manufactured by Paelra Pharmaceuticals. Inc., San Diego, California, USA
- Manufacturer
- Pacira Pharmaceuticals, Inc.
- Category
- Drug — Injectable
- Hazard
- Affected units
- 324
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 (1)
- Lot #11-2005 Control #23542 Manufacture Date: 05Dec11 2011-L-009
Distribution
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