HYDROmorphone HCl 6 mg/30mL in 0.9% Sodium Chloride Injection (0.2 mg/mL), Rx Only, a) 30 mL Plun...
FDA Recall #D-0195-2021 — Class II — December 17, 2020
Product Description
HYDROmorphone HCl 6 mg/30mL in 0.9% Sodium Chloride Injection (0.2 mg/mL), Rx Only, a) 30 mL Plungerless Single Dose Syringe (barcode 70004030016) and b) 30 mL Single Dose Syringe (barcode 70004030018), SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT, 06095
Reason for Recall
Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit
Recalling Firm
SCA Pharmaceuticals — Windsor, CT
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Drugs
Product Quantity
3,092 syringes
Distribution
Product was distributed to hospitals nationwide.
Code Information
a) Lot # 1220023171, BUD 1/26/2021; 1220023282, BUD 2/1/2021; 1220023446, BUD 2/7/2021; 1220023532, BUD 2/8/2021; 1220023650, BUD 2/11/2021 & 1220023727, BUD 2/14/2021. b) Lot # 1220023241, BUD 1/25/2021; 1220023313, BUD 2/1/2021 & 1220023442, BUD 2/7/2021.
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated