Recalls / Class I
Class ID-1553-2020
Class I— FDA's most serious classification, issued when there is a reasonable probability that use of or exposure to the drug will cause serious adverse health consequences or death.
Product
Heparin Sodium 10,000 units in 0.9% Sodium Chloride 1000 mL, Single Dose Container, Rx Only Injection for Intravenous Use (10 units/mL), SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT 06095, NDC#: 70004-0652-46, Bar Code 70004065246.
- Affected lot / code info
- Lot #: 1220019457, Exp 08/24/2020
Why it was recalled
Cross Contamination with Other Product(s): containers labeled as having methylparaben and propylparaben as preservatives, actually contained undeclared benzyl alcohol and did not contain any parabens.
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
- 362 Containers
- Distribution pattern
- Nationwide within the U.S.
Timeline
- Recall initiated
- 2020-07-29
- FDA classified
- 2020-08-27
- Posted by FDA
- 2020-09-02
- Terminated
- 2021-05-21
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1553-2020. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.