Accord Healthcare recalls phenylephrine injection vials due to manufacturing deviations
Accord Healthcare is recalling Phenylephrine Hydrochloride Injection vials due to manufacturing deviations found during FDA inspection. No illnesses or injuries have been reported.
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 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: This is an FDA Class II recall with no reported illnesses or injuries. The hazard is based on manufacturing process deviations identified during inspection—a precautionary quality-control recall rather than confirmed product contamination or harm.
Plain-English summary
Accord Healthcare, Inc. is recalling Phenylephrine Hydrochloride Injection, USP 10 mg/mL, 1 mL single-dose vials manufactured by Intas Pharmaceuticals Limited in India. The product was distributed to the United States, Puerto Rico, and Canada. The recall affects 9,888 vials from batches R2101555, R2101538, and R2101564 with an expiration date of November 30, 2023.
The recall is due to Current Good Manufacturing Practice (CGMP) deviations identified during an FDA inspection of the manufacturing facility. The FDA has classified this as a Class II recall. No illnesses or injuries associated with this product have been reported.
The recalled product
- Product
- Phenylephrine Hydrochloride Injection, USP 10 mg/mL Rx Only, 1 mL Single Dose Vial, Manufactured for: Accord Healthcare, Inc., Durham, NC 27703 Manufactured by: Intas Pharmaceuticals Limited, Pharmez, Ahmedabad-382 213, INDIA; Vial NDC 16729-464-63, UPC 3 16729 46463 5; Carton…
- Manufacturer
- Accord Healthcare, Inc.
- Hazard
- Affected units
- 9,888
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: R2101555
- R2101538
- R2101564
- 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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