FDAClass IIDecember 21, 2016

Phenylephrine HCl 1 mg/10 mL recall: Sterility Concern

Phenylephrine HCl 1 mg/10 mL (100 mcg/mL) in 0.9% Sodium Chloride, 10 mL Single-Dose Syringe, Rx Only Cantrell Drug Company 7321 Cantrell Rd Little…

Why was Phenylephrine HCl 1 mg/10 mL recalled?

Lack of Assurance of Sterility - the firm is recalling select sterile drug products.

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?

Lot: 8502 BUD: 11/21/2016, Lot: 8962 BUD: 02/21/2017

Product
Phenylephrine HCl 1 mg/10 mL (100 mcg/mL) in 0.9% Sodium Chloride, 10 mL Single-Dose Syringe, Rx Only Cantrell Drug Company 7321 Cantrell Rd Little…
Recalling firm
Cantrell Drug Company
Quantity
30,796 syringes
Distribution
Nationwide
Recall date
December 21, 2016
Classification
Class II
Status
Terminated
Agency
FDA (drug)
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