Abbott's Compounding Pharmacy Recalls Bupivacaine Due to Sterility Concerns
Abbott's Compounding Pharmacy is recalling all unexpired lots of Bupivacaine 0.25% sterile compounded products because an FDA inspection found concerns regarding the lack of sterility assurance.
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 rating under the rubric, particularly given the risk of infection associated with a lack of sterility assurance in a sterile compounded drug.
Plain-English summary
Abbott's Compounding Pharmacy, Inc. is recalling all unexpired lots of Bupivacaine, 0.25%, 450 mL sterile compounded products. The recall was initiated after an FDA inspection identified concerns regarding the lack of assurance of sterility for these products.
The recalled products were distributed in California. The recall covers all lots of the specified sterile compounded product. No specific dates or additional distribution details are provided in the source text.
Consumers and healthcare providers should stop using the recalled products and contact their healthcare provider or the recalling firm for further instructions on how to proceed.
The recalled product
- Product
- Bupivacaine, 0.25%, 450 mL, This Rx is Compounded, Abbott's Compounding Pharmacy, Berkeley, CA 94705
- Manufacturer
- Abbott's Compounding Pharmacy, Inc.
- Category
- Drug — Compounded Sterile Drug
- 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 (1)
- All lots
Distribution
Distributed in 1 state:
Part of a larger recall action
This product is one of 43 recalled by Abbott's Compounding Pharmacy, Inc. under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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