Pharmakon Recalls Midazolam IV Bags Due to Undeclared Benzyl Alcohol
Pharmakon Pharmaceuticals is recalling specific lots of Midazolam HCl IV bags because they contain undeclared benzyl alcohol.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The agency classification is FDA Class I, which mandates a minimum severity score of 4 according to the rubric.
Plain-English summary
Pharmakon Pharmaceuticals is recalling specific lots of Midazolam HCl 1 mg/ml in 0.9% Sodium Chloride IV bags. The recall involves 50 mL and 100 mL bags labeled for prescription use only. The affected products are identified by specific lot numbers and expiration dates provided in the recall notice.
The reason for the recall is that the product contains an undeclared excipient, specifically benzyl alcohol. This ingredient was not listed on the product labeling. The recall is classified as Class I by the U.S. Food and Drug Administration.
The affected products were distributed in Texas, Illinois, Maryland, and Indiana. Healthcare providers and patients who have received these specific lots of Midazolam HCl should stop using them and contact Pharmakon Pharmaceuticals or their healthcare provider for further instructions.
The recalled product
- 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.
- Manufacturer
- Pharmakon Pharmaceuticals
- Category
- Drug — IV Infusion
- Hazard
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (3)
- A) Lot #: E21294DK1C
- Exp Date: 05/22/2014 B) Lot #: E21294DK3C
- Exp Date: 06/08/2014
Distribution
Part of a larger recall action
This product is one of 4 recalled by Pharmakon Pharmaceuticals under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 4 products in this recall →Related recalls
Same manufacturer · Pharmakon Pharmaceuticals
See all →- CriticalPharmakon Recalls Morphine Sulfate Syringes Due to High Potency
FDA (Drugs) · 2016-06-01
- ModeratePharmakon Recalls Midazolam Syringes Due to Insufficient Stability Data
FDA (Drugs) · 2016-02-03
- ModeratePharmakon Recalls Provocholine Pre-diluted Sets Due to Stability Data Issues
FDA (Drugs) · 2016-02-03
- ModeratePharmakon Recalls Ketamine Syringes Due to Insufficient Stability Data
FDA (Drugs) · 2016-02-03
- ModeratePharmakon Recalls Provocholine Pre-diluted Sets Due to Stability Data Concerns
FDA (Drugs) · 2016-02-03
Same hazard · undeclared excipient
See all →- CriticalLubrisine eye drops recalled for undeclared colloidal silver and sterility issues
FDA (Drugs) · 2018-12-26
- ModerateImprimisRx Recalls Timolol-Latanoprost Ophthalmic Drops Due to Mislabeling
FDA (Drugs) · 2017-09-13
- ModerateImprimisRx Recalls Latanoprost Ophthalmic Drops Due to Undeclared Excipient
FDA (Drugs) · 2017-09-13
- SevereImprimisRx Recalls Timolol Ophthalmic Drops Due to Undeclared Excipient
FDA (Drugs) · 2017-09-13
- SevereImprimisRx Recalls Curcumin Emulsion Injection Due to Undeclared Excipient
FDA (Drugs) · 2017-09-13