Pfizer Recalls Unasyn Injection Due to Particulate Matter
Pfizer is recalling specific lots of Unasyn (ampicillin sodium and sulbactam sodium) for injection because particulate matter was identified after reconstitution.
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 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II, and the presence of particulate matter in an injectable drug presents a risk of harm, fitting the criteria for a High severity score.
Plain-English summary
Pfizer Inc. is recalling 94,320 units of Unasyn (ampicillin sodium and sulbactam sodium) for injection, 1.5 g per vial. The affected product is identified by Lot # 3301612 with an expiration date of 02/2022. The recall was initiated because particulate matter was identified in the medication after it was reconstituted.
The affected product was distributed nationwide in the United States. Unasyn is a prescription-only medication administered via intramuscular or intravenous routes. The product is manufactured in Italy and distributed by the Roerig Division of Pfizer Inc.
Healthcare providers and patients should stop using the affected lots of Unasyn. Consumers should check their medication vials for the specific lot number and expiration date listed above. If the product matches the recalled lot, it should not be used. Patients should contact their healthcare provider for guidance on alternative treatment options.
The recalled product
- Product
- UNASYN (AMPICILLIN SODIUM AND SULBACTAM SODIUM)
- Brand
- UNASYN
- Manufacturer
- Pfizer Inc.
- Category
- Drug — Antibiotic
- Hazard
- Affected units
- 94,320
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 (2)
- Lot # 3301612
- EXP 02/2022
Distribution
Distributed nationwide across the United States.
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