labetalol HCl injection 20 mg/4 mL — Class III drug recall D-0603-2018
Terminated recall by SCA Pharmaceuticals, LLC., reported 2018-03-14, distributed in GA, NE, PA. Labeling; Incorrect or Missing Lot number/Expiration Date; some product labels incorrectly indicates a compoun
| Recall number | D-0603-2018 |
|---|---|
| Product type | Drug |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | SCA Pharmaceuticals, LLC., Windsor, CT, United States |
| Recall initiated | 2018-02-22 |
| Classified | 2018-03-19 |
| Reported by FDA | 2018-03-14 |
| Terminated | 2019-02-26 |
| Distributed | GA, NE, PA |
| Quantity | 480 syringes |
| Reason classes | labeling |
| NDC | 70004-0700-28 |
| Lot numbers | 1217000213 |
| Expiration dates | 2019-03-27 |
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
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
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-0603-2018. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.