Baxter Recalls Bupivacaine Injection Due to Particulate Matter
Baxter Healthcare is recalling specific lots of Bupivacaine Hydrochloride Injection due to the presence of black and transparent particles in the solution.
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 drug recalls.
Plain-English summary
Baxter Healthcare Corporation is recalling specific lots of Bupivacaine Hydrochloride in 8.25% Dextrose Injection, USP Spinal 0.75% (15 mg/2 mL) 10 x 2 mL single-dose ampules. The recall was initiated because of the presence of particulate matter in the solution, specifically black and transparent particles.
The affected product is manufactured for Baxter Healthcare Corporation in Deerfield, IL, and manufactured by Baxter Pharmaceuticals India Private Ltd in Ahmedabad, India. The recall covers lots A0B1241 (Exp 10/2020), A0C0091 (Exp 12/2020), and A0D0268 (Exp 02/2022). The product was distributed nationwide in the USA.
Healthcare providers and consumers should stop using the affected lots and contact Baxter Healthcare Corporation for further instructions or to arrange for a return or replacement.
The recalled product
- Product
- Bupivacaine Hydrochloride in 8.25% Dextrose Injection, USP Spinal 0.75% (15 mg/2 mL) 10 x 2 mL single-dose ampules, Rx only, Manufactured for: Baxter Healthcare Corporation Deerfield, IL 60015 USA, Manufactured by: Baxter Pharmaceuticals India Private Ltd Ahmedabad 382213 India…
- Manufacturer
- Baxter Healthcare Corporation
- Category
- Drug — 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 (6)
- Lot #: A0B1241
- Exp 10/2020
- A0C0091
- Exp 12/2020
- A0D0268
- Exp 02/2022
Distribution
Distributed nationwide across the United States.
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