FDA Drug recall D-0757-2017
PGE1/PROCAINE 5ML MDV 40MCG/ML/0.1% INJ, Injection, 40mcg/mL, 0.1%, Rx only, 5 mL Glass/Multiple Dose vial, Prepared by Key Compounding Pha…
- FDA Drug
- Class II
- terminated
- Published 2017-05-24
On 2017-05-24 the FDA classified a Class II recall of PGE1/PROCAINE 5ML MDV 40MCG/ML/0.1% INJ, Injection, 40mcg/mL, 0.1%, Rx only, 5 mL Glass/Multiple Dose vial, Prepared by Key Compounding Pha… 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-0757-2017 |
| 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
PGE1/PROCAINE 5ML MDV 40MCG/ML/0.1% INJ, Injection, 40mcg/mL, 0.1%, Rx only, 5 mL Glass/Multiple Dose vial, Prepared by Key Compounding Pharmacy
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 # t11-28-2016@86, Exp 5/22/2017; t12-19-2016@73, Exp 5/22/2017 |
|---|
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-0757-2017%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.