Recalls / Class III
Class IIID-0603-2018
Product
labetalol HCl injection 20 mg/4 mL (5mg/mL), 4 mL syringe, Rx Only, for IV Use, SCA Pharmaceuticals, Windsor, CT 06095 --- NDC 70004-0700-28, UPC 70004070028
- Affected lot / code info
- lot 1217000213, exp 03/27/2019
Why it was recalled
Labeling; Incorrect or Missing Lot number/Expiration Date; some product labels incorrectly indicates a compounding date of 12/27/2018 and use-by date of 03/27/2019 instead of 12/27/2017 and use-by-date of 03/27/2018
Recalling firm
- Firm
- SCA Pharmaceuticals, LLC.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 755 Rainbow Rd Ste B, N/A, Windsor, Connecticut 06095-1024
Distribution
- Quantity
- 480 syringes
- Distribution pattern
- GA, NE & PA
Timeline
- Recall initiated
- 2018-02-22
- FDA classified
- 2018-03-19
- Posted by FDA
- 2018-03-14
- Terminated
- 2019-02-26
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0603-2018. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.