FDA Recall D-1566-2014

Pharmakon Pharmaceuticals · Noblesville, IN

Class I — life-threatening Terminated 226 days on record

Highest impact — Class I recall — FDA determination of strong likelihood of serious adverse health consequence or death.

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.

Lot / code: A) Lot #: E21294DK1C; Exp Date: 05/22/2014 B) Lot #: E21294DK3C; Exp Date: 06/08/2014

Quantity: 10/50 mL bags, 40/100 mL bags

Reason for recall

Incorrect/ Undeclared Excipient: Contains undeclared benzyl alcohol.

Recall record

Recall number: D-1566-2014
Classification: Class I
Status: Terminated
Voluntary or mandated: Voluntary: Firm initiated
Firm notification: Telephone
Distribution: United States: TX, IL, MD, IN
Recall initiated: 2014-04-21
Classified by FDA Center: 2014-08-26
FDA published: 2014-09-03
Terminated: 2014-12-03
Recalling firm: Pharmakon Pharmaceuticals
Firm location: Noblesville, IN

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