Apothecary Shoppe Recalls Testosterone Cypionate Injectable Due to Sterility Concerns
The Apothecary Shoppe is recalling 1,430 mL of Testosterone Cypionate 200 mg/mL Injectable in Oklahoma due to concerns about sterility assurance.
The agency’s classification
FDA (Drugs): Class II
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.
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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The source text explicitly identifies the agency classification as Class II. According to the severity rubric, an FDA Class II recall involving a sterile injectable product where sterility assurance is compromised is classified as Severe (Score 4), as it poses a significant risk of infection or injury.
Plain-English summary
The Apothecary Shoppe is recalling 1,430 mL of SIH-Testosterone Cypionate 200 mg/mL Injectable, 10 mL sterile vials. The recall is limited to distribution in Oklahoma. The affected lots are 05132013@25 (Exp 11/9/13) and 08072013@4 (Exp 2/3/14).
The recall was initiated due to a lack of assurance of sterility, specifically regarding concerns with the pharmacy's independent testing laboratory. The U.S. Food and Drug Administration has classified this as a Class II recall.
Consumers and healthcare providers in Oklahoma who possess these specific lots should stop using the product and contact the recalling firm or their healthcare provider for instructions on return or disposal.
The recalled product
- Product
- SIH-Testosterone Cypionate 200 mg/mL Injectable, 10 mL sterile vial, The Apothecary Shoppe, 6136 E. 51st St. Tulsa, OK 74135.
- Manufacturer
- Apothecary Shoppe
- Category
- Drug — Injectable Steroid
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 (4)
- Lot #s: 05132013@25
- Exp 11/9/13
- 08072013@4
- Exp 2/3/14
Distribution
Distributed in 1 state:
Part of a larger recall action
This product is one of 2 recalled by Apothecary Shoppe 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.
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