FDA Drug Moderate Class II Terminated

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

Reported: August 2, 2017 Initiated: July 14, 2017 #D-1017-2017

Product Description

Reason for Recall

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

Details

Recalling Firm: SCA Pharmaceuticals
Units Affected: N/A
Distribution: Nationwide
Location: Little Rock, AR

Frequently Asked Questions

What product was recalled? ▼

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. Recalled by SCA Pharmaceuticals. Units affected: N/A.

Why was this product recalled? ▼

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

Which agency issued this recall? ▼

This recall was issued by the FDA Drug on August 2, 2017. Severity: Moderate. Recall number: D-1017-2017.