Sagent Recalls Phenylephrine Hydrochloride Injection Due to Sterility Concerns
Sagent Pharmaceuticals is recalling specific lots of Phenylephrine Hydrochloride Injection due to customer complaints of loose vial overseals that may compromise sterility.
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 and involves a lack of assurance of sterility in an intravenous product, which carries a significant risk of serious injury or hospitalization from infection.
Plain-English summary
Sagent Pharmaceuticals Inc is recalling 3,716 cartons of Phenylephrine Hydrochloride Injection, USP, 10 mg per mL. The affected product is packaged in 1 mL single-dose vials and is intended for intravenous use. The recall covers specific lots with expiration dates in August and September 2022.
The recall was initiated due to customer complaints regarding loose crimped vial overseals. This defect may result in a non-sterile product, which poses a risk of infection if administered intravenously. The agency has classified this as a Class II recall.
The affected product was distributed nationwide in the USA and Puerto Rico. Healthcare providers and patients should check their inventory for the specific lot numbers and expiration dates listed in the recall notice. If the product is found, it should be quarantined and not used.
The recalled product
- Product
- PHENYLEPHRINE HYDROCHLORIDE (PHENYLEPHRINE HYDROCHLORIDE)
- Brand
- PHENYLEPHRINE HYDROCHLORIDE
- Manufacturer
- Sagent Pharmaceuticals Inc
- Category
- Drug — Injection
- Affected units
- 3,716
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 (5)
- Lots: PHT8IB2
- PHT9IB2
- exp 08/2022
- PHT1JB2
- exp 09/2022
Distribution
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