Hydroxocobalamin 1 mg/mL 30 mL Vial For IM Use — Class II drug recall D-0181-2018
Terminated recall by KRS Global Biotechnology, Inc, reported 2018-01-17, distributed nationwide. Labeling: Incorrect or Missing Lot and/or Exp Date: Beyond Use Date (BUD) exceed the BUD/EXP of at least one i
| Recall number | D-0181-2018 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | KRS Global Biotechnology, Inc, Boca Raton, FL, United States |
| Recall initiated | 2017-11-16 |
| Classified | 2018-01-08 |
| Reported by FDA | 2018-01-17 |
| Terminated | 2020-05-11 |
| Distributed | Nationwide (US) |
| Countries outside the US | BM, NZ |
| Quantity | 596 vials |
| Reason classes | labeling |
| Expiration dates | 2018-02-13 |
Product
Hydroxocobalamin 1 mg/mL 30 mL Vial For IM Use, Rx Only, KRS Global Biotechnology, 791 Park of Commerce Blvd, Boca Raton, FL 33487.
Reason for recall
Labeling: Incorrect or Missing Lot and/or Exp Date: Beyond Use Date (BUD) exceed the BUD/EXP of at least one ingredient used to make final product.
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-0181-2018. 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.