Strohecker's Pharmacy Recalls Testosterone Cypionate Vials Due to Incorrect Formulation
Strohecker's Pharmacy is recalling 365 vials of Testosterone Cypionate 200 mg/mL because they contain Estradiol Valerate 20 mg/mL instead.
The agency’s classification
FDA (Drugs): Class I
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.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 5/5 (Critical).
Highest-severity recall. The hazard can cause serious injury or death. Stop using the product now and follow the agency's instructions.
Our severity reasoning: The agency classification is FDA Class I, which mandates a severity score of 5 according to the rubric.
Plain-English summary
Strohecker's Pharmacy is recalling 365 vials of Testosterone Cypionate 200 mg/mL in Sesame Oil, 10 mL amber glass vials, Rx Only, Lot # T-1201S14, Exp 5/30/2015. The product was compounded by Strohecker's Pharmacy and distributed nationwide.
The recall was initiated because the vials are labeled as Testosterone Cypionate 200 mg/mL in Sesame Oil but actually contain Estradiol Valerate 20 mg/mL. This constitutes an incorrect product formulation.
Consumers who have this specific lot of product should stop using it and contact their healthcare provider or pharmacist for guidance on proper disposal or replacement.
The recalled product
- Product
- Testosterone Cypionate 200 mg/mL in Sesame oil, 10 mL amber glass vial, Rx Only, Lot# T-1201S14, Compounded by Strohecker's Pharmacy.
- Manufacturer
- Stroheckers Inc Pharmacy
- Category
- Drug — Compounded Prescription
- Affected units
- 365
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 (2)
- Lot # T-1201S14
- Exp 5/30/2015
Distribution
Distributed nationwide across the United States.
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