HYDROmorphone HCL in 0.9% Sodium Chloride injectable, 0.2 mg per ml, Total Volume 100mL, Single Dose Container bag, (Total HYDROmorphone Dose 20 mg per 100 mL) Preservative Free, Rx Only, SCA Pharmaceuticals, 8821 Knoedl Ct. Little Rock, AR 72205, NDC 70004-0300-55
Reported: June 7, 2017 Initiated: May 18, 2017 #D-0875-2017
Product Description
HYDROmorphone HCL in 0.9% Sodium Chloride injectable, 0.2 mg per ml, Total Volume 100mL, Single Dose Container bag, (Total HYDROmorphone Dose 20 mg per 100 mL) Preservative Free, Rx Only, SCA Pharmaceuticals, 8821 Knoedl Ct. Little Rock, AR 72205, NDC 70004-0300-55
Reason for Recall
Lack of assurance of sterility: Product bags leaking at seam.
Details
- Recalling Firm
- SCA Pharmaceuticals
- Units Affected
- 87 bags
- Distribution
- Nationwide in the USA
- Location
- Little Rock, AR
Frequently Asked Questions
What product was recalled? ▼
HYDROmorphone HCL in 0.9% Sodium Chloride injectable, 0.2 mg per ml, Total Volume 100mL, Single Dose Container bag, (Total HYDROmorphone Dose 20 mg per 100 mL) Preservative Free, Rx Only, SCA Pharmaceuticals, 8821 Knoedl Ct. Little Rock, AR 72205, NDC 70004-0300-55. Recalled by SCA Pharmaceuticals. Units affected: 87 bags.
Why was this product recalled? ▼
Lack of assurance of sterility: Product bags leaking at seam.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on June 7, 2017. Severity: Moderate. Recall number: D-0875-2017.
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