FDA Drug recall D-1566-2014
Midazolam HCl 1 mg/ml in 0.9% Sodium Chloride in 50 mL and 100 mL IV bag, Rx Only
- FDA Drug
- Class I
- terminated
- Published 2014-09-03
On 2014-09-03 the FDA classified a Class I recall of Midazolam HCl 1 mg/ml in 0.9% Sodium Chloride in 50 mL and 100 mL IV bag, Rx Only by Pharmakon Pharmaceuticals, citing incorrect/ Undeclared Excipient: Contains undeclared benzyl alcohol.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-1566-2014 |
| Classification | Class I |
| Status | terminated |
| Initiated | 2014-04-21 |
| Published | 2014-09-03 |
| Last updated | 2026-09-13 11:51 UTC |
| Company | Pharmakon Pharmaceuticals |
| Distribution | IL, IN, MD, TX |
Product
Midazolam HCl 1 mg/ml in 0.9% Sodium Chloride in 50 mL and 100 mL IV bag, Rx Only. Labeled A) 50 mL, Pharmakon Pharmaceuticals, Inc., 14450 Getz Rd., Noblesville, IN 46060. NDC#: 45183-0989-41. B) 100 mL, Pharmakon Pharmaceuticals, 14450 Getz Rd., Noblesville, IN 888-660-6715. NDC#: 45183-0796-48.
Reason
Incorrect/ Undeclared Excipient: Contains undeclared benzyl alcohol.
Identifiers
| code_info | A) Lot #: E21294DK1C; Exp Date: 05/22/2014 B) Lot #: E21294DK3C; Exp Date: 06/08/2014 |
|---|
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-1566-2014%22
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