Aurobindo Recalls Ampicillin and Sulbactam Injection Due to Glass Particulates
Aurobindo Pharma is recalling 53,040 vials of Ampicillin and Sulbactam for Injection due to a confirmed report of visible glass particulate matter.
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 5/5 (Critical).
Highest-severity recall. The hazard can cause serious injury or death. Stop using the product now and follow the agency's instructions.
Our severity reasoning: The FDA has classified this recall as Class I, which meets the rubric criteria for a Critical severity score.
Plain-English summary
Aurobindo Pharma Ltd. is recalling 53,040 vials of Ampicillin and Sulbactam for Injection, 1.5 g. The product is a sterile dry powder for intramuscular or intravenous injection, distributed nationwide in the USA by AuroMedics Pharma LLC. The specific lot number is AF0117001-A.
The recall was initiated following a confirmed customer report of visible particulate matter within a single vial. The particulate matter was confirmed to be glass. The FDA has classified this recall as Class I, indicating a reasonable probability that use of the product could cause serious adverse health consequences or death.
Healthcare providers and patients should stop using the affected product immediately. Consumers should check their medication for the specific lot number and contact their healthcare provider or pharmacist for instructions on how to return the product or obtain a replacement.
The recalled product
- Product
- AMPICILLIN AND SULBACTAM (AMPICILLIN SODIUM AND SULBACTAM SODIUM)
- Brand
- AMPICILLIN AND SULBACTAM
- Manufacturer
- Aurobindo Pharma Ltd.
- Category
- Drug — Antibiotic Injection
- Affected units
- 53,040
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 Number AF0117001-A
UPCs (4)
- 0355150116201
- 0355150179992
- 0355150178995
- 0355150117208
Distribution
Distributed nationwide across the United States.
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