Recalls / Class II
Class IID-0875-2017
Product
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
- Affected lot / code info
- LOT # 20170505@23, 20170505@28, Use By: 08/03/17
Why it was recalled
Lack of assurance of sterility: Product bags leaking at seam.
Recalling firm
- Firm
- SCA Pharmaceuticals
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 8821 Knoedl Ct, Little Rock, Arkansas 72205-4600
Distribution
- Quantity
- 87 bags
- Distribution pattern
- Nationwide in the USA
Timeline
- Recall initiated
- 2017-05-18
- FDA classified
- 2017-05-31
- Posted by FDA
- 2017-06-07
- Terminated
- 2018-03-29
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0875-2017. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.