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Recall Observatory FDA recall evidence

Drug 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

D-0603-2018

February 22, 2018

Class III

Product summary

Firm
SCA Pharmaceuticals, LLC.
Event
Event 79265
Status
Terminated
Classification
Class III
Quantity
480 syringes
Official record key
drug-enforcement:D-0603-2018

Official wording

Reason: 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

Code information: lot 1217000213, exp 03/27/2019

Distribution pattern: GA, NE & PA

Derived failure modes

  • Labeling or packaging

    reason.labeling_packaging · v1.0.0

    Labeling; Incorrect or Missing