Phenylephrine HCl 1 mg/10 mL (100 mcg/mL) in 0.9% Sodium Chloride, 10 mL Single-Dose Syringe, Rx ...
FDA Recall #D-0185-2017 — Class II — November 18, 2016
Product Description
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 Rock, AR 72207, NDC 52533-171-12
Reason for Recall
Lack of Assurance of Sterility - the firm is recalling select sterile drug products.
Recalling Firm
Cantrell Drug Company — Little Rock, AR
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Drugs
Product Quantity
30,796 syringes
Distribution
Nationwide
Code Information
Lot: 8502 BUD: 11/21/2016, Lot: 8962 BUD: 02/21/2017
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated