April 2015 FDA Recall Drug by Stroheckers Inc Pharmacy
D-1088-2015 - Incorrect Product Formulation
This Class I drug recall was voluntarily initiated by Stroheckers Inc Pharmacy on April 12, 2015 for the product Drug. The FDA reported the reason for recall as incorrect product formulation. The product was distributed Nationwide and the recall is currently terminated.
Recall Number: D-1088-2015
Incorrect Product Formulation: Vials labeled as Testosterone Cypionate 200 mg/mL in Sesame Oil are being recalled because they contains Estradiol Valerate 20 mg/mL.
04-12-2015
06-03-2015
365 vials
Recall Profile & Regulatory Data
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.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Stroheckers Inc Pharmacy
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Nationwide
02-01-2016
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Testosterone Cypionate 200 mg/mL in Sesame oil, 10 mL amber glass vial, Rx Only, Lot# T-1201S14, Compounded by Strohecker's Pharmacy.
Batch or Lot Expiration Information
Lot# T-1201S14, Exp 5/30/2015
