Multi-event April 2014 FDA Recall Drug by Pharmakon Pharmaceuticals

This Multi-event Class I drug recall was voluntarily initiated by Pharmakon Pharmaceuticals on April 21, 2014 for the product Drug. The FDA reported the reason for recall as incorrect/ undeclared excipient. The product was distributed in United States: TX, IL, MD, IN and the recall is currently terminated.

Reported Recall Events

D-1565-2014 TERMINATED D-1568-2014 TERMINATED D-1567-2014 TERMINATED D-1566-2014 TERMINATED

Recall Number: D-1565-2014

Reason for Recall
Incorrect/ Undeclared Excipient: Contains undeclared benzyl alcohol.
Initiated
04-21-2014
Reported
09-03-2014
Quantity
20 vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
68191
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class I - is a situation in which there is a reasonable probability that the use of, or exposure to, a violative product will cause serious adverse health consequences or death.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Pharmakon Pharmaceuticals
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
United States: TX, IL, MD, IN
Termination Date About Termination Date
Date that FDA officially terminated the recall.
12-03-2014
Product Description About Product Description
Full technical description of the product.
Midazolam HCl 2 mg/ml in 0.9% Sodium Chloride in 30 mL PVC Vial, Rx Only. Pharmakon Pharmaceuticals, Inc., 14450 Getz Rd., Noblesville IN 46060 NDC#: 45183-0234-68.

Batch or Lot Expiration Information

Lot# : E21294K3C Exp Date: 6/29/2014

Recall Number: D-1568-2014

Reason for Recall
Incorrect/ Undeclared Excipient: Contains undeclared benzyl alcohol.
Initiated
04-21-2014
Reported
09-03-2014
Quantity
5 Syringes

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
68191
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class I - is a situation in which there is a reasonable probability that the use of, or exposure to, a violative product will cause serious adverse health consequences or death.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Pharmakon Pharmaceuticals
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
United States: TX, IL, MD, IN
Termination Date About Termination Date
Date that FDA officially terminated the recall.
12-03-2014
Product Description About Product Description
Full technical description of the product.
Atropine Sulfate 0.4 mg/ml Injection, USP, Total Dosage 0.8 mg per 2 mL, 3 mL pre-filled syringe, Rx Only. Pharmakon Pharmaceuticals, Inc., 14450 Getz Road, Noblesville, IN. NDC: 45183-0105-78.

Batch or Lot Expiration Information

Lot# : E0333282R; Exp: 7/13/2014

Recall Number: D-1567-2014

Reason for Recall
Incorrect/ Undeclared Excipient: Contains undeclared benzyl alcohol.
Initiated
04-21-2014
Reported
09-03-2014
Quantity
200 Syringes

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
68191
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Pharmakon Pharmaceuticals
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
United States: TX, IL, MD, IN
Termination Date About Termination Date
Date that FDA officially terminated the recall.
12-03-2014
Product Description About Product Description
Full technical description of the product.
Glycopyrrolate 0.2 mg/ml, 5 mL pre-filled syringe, Rx Only. Pharmakon Pharmaceuticals, Inc., 14450 Getz Rd., Noblesville, IN 46060, NDC#: 45183-0965-70.

Batch or Lot Expiration Information

Lot# : E131210.212 Exp: 07/14/2014

Recall Number: D-1566-2014

Reason for Recall
Incorrect/ Undeclared Excipient: Contains undeclared benzyl alcohol.
Initiated
04-21-2014
Reported
09-03-2014
Quantity
10/50 mL bags, 40/100 mL bags

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
68191
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class I - is a situation in which there is a reasonable probability that the use of, or exposure to, a violative product will cause serious adverse health consequences or death.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Pharmakon Pharmaceuticals
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
United States: TX, IL, MD, IN
Termination Date About Termination Date
Date that FDA officially terminated the recall.
12-03-2014
Product Description About Product Description
Full technical description of the 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.

Batch or Lot Expiration Information

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