FDA Drug recall D-0724-2017
HYDROXO-B12 10ML PBF MDV 5MG/ML INJ, 5mg/mL, Rx only, 10 mL Glass/ Multiple Dose vial, Prepared by Key Compounding Pharmacy HYDROXO-B12 30M…
- FDA Drug
- Class II
- terminated
- Published 2017-05-24
On 2017-05-24 the FDA classified a Class II recall of HYDROXO-B12 10ML PBF MDV 5MG/ML INJ, 5mg/mL, Rx only, 10 mL Glass/ Multiple Dose vial, Prepared by Key Compounding Pharmacy HYDROXO-B12 30M… by Key Pharmacy And Compounding Center, citing lack of Assurance of Sterility: The firm is recalling sterile compounded drugs within expiry due to lack of assurance of sterility.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0724-2017 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2017-04-18 |
| Published | 2017-05-24 |
| Last updated | 2026-09-13 11:51 UTC |
| Company | Key Pharmacy And Compounding Center |
| Distribution | US |
Product
HYDROXO-B12 10ML PBF MDV 5MG/ML INJ, 5mg/mL, Rx only, 10 mL Glass/ Multiple Dose vial, Prepared by Key Compounding Pharmacy HYDROXO-B12 30ML PBF MDV 5MG/ML INJ, 5mg/mL, RX only, 30 mL Glass/ Multiple Dose vial.
Reason
Lack of Assurance of Sterility: The firm is recalling sterile compounded drugs within expiry due to lack of assurance of sterility.
Identifiers
| code_info | Lot # t01-20-2017@87, Exp 4/23/2017; t02-08-2017@99, Exp 4/30/2017; t02-21-2017@113, Exp 4/30/2017. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:51 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0724-2017%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.