Phenylephrine Hydrochloride Injection Recalled for Manufacturing Practice Deviations
Accord Healthcare is recalling 5,090 vials of Phenylephrine Hydrochloride Injection due to manufacturing deviations found during an FDA inspection. Affected batches include R2101570, R2101574, and R2101576, distributed in the United States, Puerto Rico, and Canada.
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: This recall received a High score because it involves a risk-of-harm product (injectable medication with manufacturing process deviations) where no injury has been reported. The FDA Class II classification confirms potential for serious adverse health consequences, meeting the rubric criterion for high-risk products.
Plain-English summary
Accord Healthcare, Inc. is recalling 5,090 vials of Phenylephrine Hydrochloride Injection, USP (10 mg/mL, 5 mL vials) due to Current Good Manufacturing Practice (CGMP) deviations identified during an FDA inspection. The FDA classified this as a Class II recall.
The recalled product was distributed throughout the United States, including Puerto Rico and Canada. The affected vials include batches R2101570, R2101574, and R2101576 with an expiration date of November 30, 2023. The product is identified by NDC 16729-465-31 (individual vials) and NDC 16729-465-03 (cartons).
Healthcare providers and hospitals should immediately discontinue use of vials from the affected batches. Affected product should be returned to the pharmacy or distributor. Patients currently receiving this medication should consult with their healthcare provider to confirm they received product from an unaffected batch.
The recalled product
- Product
- Phenylephrine Hydrochloride Injection, USP, 50 mg/5mL (10 mg/mL), Rx Only, 5 mL Vial, Manufactured for: Accord Healthcare, Inc., Durham, NC 27703 Manufactured by: Intas Pharmaceuticals Limited, Pharmez, Ahmedabad-382 213, INDIA; Vial NDC 16729-465-31, UPC 3 16729 46531 1; Carton…
- Manufacturer
- Accord Healthcare, Inc.
- Category
- Drug — Injection
- Hazard
- Affected units
- 5,090
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 (4)
- Batches: R2101570
- R2101574
- R2101576
- Exp. Date 11/30/2023
Distribution
Distributed in 1 state:
Part of a larger recall action
This product is one of 67 recalled by Accord Healthcare, Inc. under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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