Phenylephrine Hydrochloride Injection recalled due to manufacturing practice deviations
Accord Healthcare is recalling Phenylephrine Hydrochloride Injection vials due to manufacturing practice deviations discovered during an FDA inspection. Affected batches were distributed in the United States, Puerto Rico, and Canada.
What this means for you
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 is a Class II FDA recall involving manufacturing practice deviations in an injectable medication, which is a risk-of-harm product. No illnesses or injuries have been reported in the source text.
Plain-English summary
Accord Healthcare, Inc. is recalling Phenylephrine Hydrochloride Injection, USP 100 mg/10 mL vials due to Current Good Manufacturing Practices (CGMP) deviations discovered during an FDA inspection.
The recall affects batches R2101591, R2101590, and R2101599, with expiration dates of November 30, 2023. Approximately 37,691 vials were distributed across the United States, Puerto Rico, and Canada.
The product is manufactured by Intas Pharmaceuticals Limited in India and was distributed by Accord Healthcare, Inc., located in Durham, North Carolina. Affected consumers and healthcare providers should contact the recalling firm for information regarding their product and appropriate next steps.
The recalled product
- Product
- Phenylephrine Hydrochloride Injection, USP 100 mg/10 mL (10 mg/mL), Rx Only, 10 mL Vial, Manufactured for: Accord Healthcare, Inc., Durham, NC 27703 Manufactured by: Intas Pharmaceuticals Limited, Pharmez, Ahmedabad-382 213, INDIA; NDC 16729-466-03, UPC 3 16729 46603 5
- Manufacturer
- Accord Healthcare, Inc.
- Category
- Drug — Injectable / Prescription
- Hazard
- manufacturing-deviation
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: R2101591
- R2101590
- R2101599
- Exp. Date 11/30/2023
Distribution
Distribution scope not specified by the agency.
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