AuroMedics Recalls Ampicillin and Sulbactam Injection Due to Particulate Matter
AuroMedics Pharma LLC is recalling 54,720 vials of Ampicillin and Sulbactam for Injection due to confirmed reports of visible red rubber particles.
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: The agency classification is FDA Class I, which mandates a minimum severity score of 4 according to the rubric.
Plain-English summary
AuroMedics Pharma LLC is recalling 54,720 vials of Ampicillin and Sulbactam for Injection, USP, 3 gram*s/vial. The product is intended for intramuscular or intravenous use and was distributed nationwide in the USA and Puerto Rico. The specific lots affected are AS0317041-A and AS0317035-A, which have an expiration date of August 2019.
The recall was initiated due to a confirmed customer report of visible particulate matter in the product. The particles are believed to be red rubber originating from the manufacturing process of the active ingredients. The product is manufactured for AuroMedics Pharma LLC and carries the NDC 55150-117-20.
Healthcare providers and patients should stop using the affected lots immediately. Consumers should check their medication vials for the specific lot numbers and expiration dates listed above. If the product matches the recalled description, it should be returned to the pharmacy or healthcare provider for disposal or replacement.
The recalled product
- Product
- AMPICILLIN AND SULBACTAM (AMPICILLIN SODIUM AND SULBACTAM SODIUM)
- Brand
- AMPICILLIN AND SULBACTAM
- Manufacturer
- AuroMedics Pharma LLC
- Category
- Drug — Antibiotic Injection
- Affected units
- 54,720
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 #: AS0317041-A
- AS0317035-A
- Exp August 2019
UPCs (4)
- 0355150116201
- 0355150179992
- 0355150178995
- 0355150117208
Distribution
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