Ropivacaine Hydrochloride Injection Recalled for Particulate Matter
Amneal Pharmaceuticals is recalling Ropivacaine Hydrochloride Injection 0.5% due to the presence of particulate matter. The recall affects specific lots distributed nationwide.
The agency’s classification
FDA (Drugs): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
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: This is classified as FDA Class I, which per the rubric warrants a score of at least 4. Particulate matter in injectable anesthetics poses a risk of serious harm if administered, and the Class I designation reflects the agency's determination of potential for serious health consequences.
Plain-English summary
Amneal Pharmaceuticals, LLC is recalling Ropivacaine Hydrochloride Injection, USP, 0.5% (500 mg per 100 mL) due to the presence of particulate matter in the product. The affected lots are AL240003 and AL240004, with an expiration date of 01/31/2026. The product was manufactured by Amneal Pharmaceuticals Pvt. Ltd. in Mehsana, India and distributed by Amneal Pharmaceuticals LLC in Bridgewater, New Jersey.
The recalled product is used for epidural, infiltration, and perineural administration. A total of 62 bags (12x100mL) have been distributed nationwide in the United States.
Healthcare providers and patients who have received or are in possession of the recalled product should stop use immediately and contact Amneal Pharmaceuticals or their healthcare provider with questions or concerns.
The recalled product
- Product
- ROPIVACAINE HYDROCHLORIDE (ROPIVACAINE HYDROCHLORIDE)
- Brand
- ROPIVACAINE HYDROCHLORIDE
- Manufacturer
- Amneal Pharmaceuticals, LLC
- 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)
- Lot #'s: AL240003
- AL240004
- Exp.: 01/31/2026
UPCs (9)
- 0370121173533
- 0370121173434
- 0370121173335
- 0370121173311
- 0370121173410
- 0370121173519
- 0370121173397
- 0370121173298
- 0370121173212
Distribution
Distributed nationwide across the United States.
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