HYDROmorphone HCl 30 mg/30 mL in 0.9% Sodium Chloride Injection (1 mg/mL) a) 30 mL Plungerless Si...
FDA Recall #D-0196-2021 — Class II — December 17, 2020
Product Description
HYDROmorphone HCl 30 mg/30 mL in 0.9% Sodium Chloride Injection (1 mg/mL) a) 30 mL Plungerless Single Dose Syringe (barcode 70004030316) and b) 30 mL Single Dose Syringe (barcode 70004030321), Rx Only, 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
1,056 syringes
Distribution
Product was distributed to hospitals nationwide.
Code Information
a) Lot # 1220022964, BUD 1/19/2021; 1220023280, BUD 2/1/2021 & 1220023623, BUD 2/10/2021. b) Lot # 1220023347, BUD 2/17/2021.
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated