Labetalol 20 mg/4 mL — Class II drug recall D-1212-2019
Terminated recall by CMC Enterprise Pharmacy, reported 2019-05-01, distributed in NC. Lack of sterility assurance.
| Recall number | D-1212-2019 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | CMC Enterprise Pharmacy, Charlotte, NC, United States |
| Recall initiated | 2019-04-12 |
| Classified | 2019-04-23 |
| Reported by FDA | 2019-05-01 |
| Terminated | 2019-10-30 |
| Distributed | NC |
| Quantity | 6,667 syringes |
| Reason classes | sterility |
| Lot numbers | EA241908, EB011905, EB081909, EB151910, EB251909, EC061907, EC151906 |
| Expiration dates | 2019-04-24, 2019-05-02, 2019-05-09, 2019-05-16, 2019-05-26, 2019-06-04, 2019-06-13 |
Product
Labetalol 20 mg/4 mL, 20 mg in 4 mL syringe, Made by: Enterprise Pharmacy, 4400 Golf Acres Drive, Bldg. J Suite E, Charlotte, NC, 28208.
Reason for recall
Lack of sterility assurance.
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-1212-2019. 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.