Reported Mar 14, 2018 · Terminated
labetalol HCl injection 20 mg/4 mL (5mg/mL), 4 mL syringe, Rx Only, for IV Use, SCA Pharmaceuticals, Windsor, CT 06095…
SCA Pharmaceuticals, LLC.
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: SCA Pharmaceuticals, LLC. · 755 Rainbow Rd Ste B · Windsor, CT · 06095-1024
Is this the product you have?
- 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
- Lot codes and dates
lot 1217000213exp 03/27/2019
- Amount recalled
- 480 syringes
Where it was sold
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
This product is unlikely to cause harm, but it breaks a safety or labelling rule.
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