FDA-Drug2017-11-08Class II

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

SCA Pharmaceuticals, LLC
Hazard

Lack Of Assurance Of Sterility.

Sold states
Nationwide in the United States
Affected count
128 syringes
Manufactured in
8821 Knoedl Ct, N/A, Little Rock, AR, United States
Products
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

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0060-2018

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