Recalls / Class II
Class IID-1311-2020
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 #: 1220017764, exp. date June 24, 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, Windsor, Connecticut 06095-1024
Distribution
- Quantity
- 333 bags
- Distribution pattern
- Product was distributed to hospitals in PA and CA.
Timeline
- Recall initiated
- 2020-06-16
- FDA classified
- 2020-06-17
- Posted by FDA
- 2020-06-24
- Terminated
- 2021-03-17
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1311-2020. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.