D-0603-2018 Class III Terminated
FDA drug recall D-0603-2018 was initiated by SCA Pharmaceuticals, LLC. on Feb 22, 2018 and is designated Class III. Reason for recall: 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… The recall status is terminated (terminated Feb 26, 2019). Affected quantity: 480 syringes.
Recall Details
- Product Type
- Drugs
- Report Date
- Mar 14, 2018
- Initiation Date
- Feb 22, 2018
- Termination Date
- Feb 26, 2019
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 480 syringes
Product Description
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
Reason for Recall
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
Distribution Pattern
GA, NE & PA
Code Information
lot 1217000213, exp 03/27/2019
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-0603-2018
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 25, 2026