Recalls / Class II
Class IID-1495-2020
Product
Heparin Sodium 5,000 units in 0.9% Sodium Chloride 1000 mL bag (5 units/mL), Rx only, SCA Pharmaceuticals 755 Rainbow Rd. Windsor, CT 06095, NDC 70004-0650-46
- Affected lot / code info
- Lot #: 1220018755, Exp. Date 7/30/2020; 1220018861, 1220018850, Exp. Date 8/4/2020; 1220018899, Exp. Date 8/5/2020; 1220019027, Exp. Date 8/11/2020; 1220019075, Exp. Date 8/12/2020; 1220019243, Exp. Date 8/20/2020; 1220019439, 1220019279, 1220019392, Exp. Date 8/24/2020; 1220019488, Exp. Date 8/26/2020
Why it was recalled
Subpotent Drug: Out-of-Specification potency results at the 30-day stability timepoint.
Recalling firm
- Firm
- SCA Pharmaceuticals
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 755 Rainbow Rd Ste B, N/A, Windsor, Connecticut 06095-1024
Distribution
- Quantity
- 3,932 bags
- Distribution pattern
- Product was distributed nationwide within the United States.
Timeline
- Recall initiated
- 2020-07-29
- FDA classified
- 2020-08-12
- Posted by FDA
- 2020-08-19
- Terminated
- 2021-03-17
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1495-2020. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.