PlainRecalls
FDA Drug Moderate Class II Terminated

HYDROmorphone HCL 1 mg per mL in 0.9% Sodium Chloride 25 mL Fill in 30 mL single-dose syringe (Total Dose Hydromorphone 25 mg/25 mL) Rx Only SCA Pharmaceuticals 8821 Knoedl Ct Little Rock, AR NDC 70004-0303-17

Reported: November 8, 2017 Initiated: October 19, 2017 #D-0060-2018

Product Description

HYDROmorphone HCL 1 mg per mL in 0.9% Sodium Chloride 25 mL Fill in 30 mL single-dose syringe (Total Dose Hydromorphone 25 mg/25 mL) Rx Only SCA Pharmaceuticals 8821 Knoedl Ct Little Rock, AR NDC 70004-0303-17

Reason for Recall

Lack Of Assurance Of Sterility.

Details

Recalling Firm
SCA Pharmaceuticals, LLC
Units Affected
128 syringes
Distribution
Nationwide in the United States
Location
Little Rock, AR

Frequently Asked Questions

What product was recalled?
HYDROmorphone HCL 1 mg per mL in 0.9% Sodium Chloride 25 mL Fill in 30 mL single-dose syringe (Total Dose Hydromorphone 25 mg/25 mL) Rx Only SCA Pharmaceuticals 8821 Knoedl Ct Little Rock, AR NDC 70004-0303-17. Recalled by SCA Pharmaceuticals, LLC. Units affected: 128 syringes.
Why was this product recalled?
Lack Of Assurance Of Sterility.
Which agency issued this recall?
This recall was issued by the FDA Drug on November 8, 2017. Severity: Moderate. Recall number: D-0060-2018.