Phenylephrine Hydrochloride Injection recall: CGMP Deviations
Phenylephrine Hydrochloride Injection, USP 10 mg/mL Rx Only, 1 mL Single Dose Vial, Manufactured for: Accord Healthcare, Inc., Durham, NC 27703…
Why was Phenylephrine Hydrochloride Injection recalled?
CGMP Deviations: recalling drug products following an FDA inspection.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Batches: R2101555, R2101538, R2101564, Exp. Date 11/30/2023;
- Product
- Phenylephrine Hydrochloride Injection, USP 10 mg/mL Rx Only, 1 mL Single Dose Vial, Manufactured for: Accord Healthcare, Inc., Durham, NC 27703…
- Recalling firm
- Accord Healthcare, Inc.
- Quantity
- 9,888 vials
- Distribution
- United States including Puerto Rico and Canada
- Recall date
- March 8, 2023
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (drug)