Hydromorphone 0.5 mg/mL in 0.9% Sodium Chloride 1 mL Fill in 3 mL BD syringe, Rx only, SCA Pharmaceuticals 8821 Knoedl Ct Little Rock, AR 72205 --- NDC# 70004-0302-05

Recall Number: D-1017-2017

Firm: SCA Pharmaceuticals

Classification: Class II

Status: Terminated

Report Date: 20170802

Initiation Date: 20170714

Termination Date: 20190501

Lack of Assurance of Sterility; product has the potential to leak.

Hydromorphone 0.5 mg/mL in 0.9% Sodium Chloride 1 mL Fill in 3 mL BD syringe, Rx only, SCA Pharmaceuticals 8821 Knoedl Ct Little Rock, AR 72205 --- NDC# 70004-0302-05