US Compounding Recalls Testosterone Vials Due to Sterility Assurance Concerns
US Compounding Inc is recalling 1,386 vials of Testosterone EO-Pro-Cyp 220 due to deficient practices that may impact sterility assurance.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II. According to the rubric, FDA Class II recalls involving significant injury or property damage reports, or structural defects, are rated as Severe (4). While no specific injuries are reported in the text, the potential for serious harm from non-sterile injectable medications justifies a high severity rating under the Class II criteria.
Plain-English summary
US Compounding Inc is recalling 1,386 vials of Testosterone EO-Pro-Cyp 220 (220 mg/mL) 30 mL Multi-Dose Vial. The product is a prescription-only medication intended for deep intramuscular injection. The recall covers specific lots with expiration dates ranging from October 2015 to January 2016.
The recall was initiated due to a lack of assurance of sterility. The firm identified deficient practices that may have an impact on sterility assurance for all sterile preparations within their expiry. The affected products were distributed nationwide.
Consumers and healthcare providers should stop using the affected vials and contact their healthcare provider or the recalling firm for further instructions. The specific lot codes and best-use-by dates are listed in the structured product information.
The recalled product
- Product
- Testosterone EO-Pro-Cyp 220 (220 mg/mL) 30 mL Multi-Dose Vial, For Deep IM Injection Only, Rx only, Compounded by US Compounding Pharmacy, Conway, Arkansas, 72653, NDC 62295-2169-06
- Manufacturer
- US Compounding Inc
- Affected units
- 1,386
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 (7)
- Lot Code: 20151006@46 BUD: 12/7/2015
- 20151607@40 BUD: 1/12/2016
- 20152005@32 BUD: 11/16/2015
- 20152304@28 BUD: 10/20/2015
- 20152304@5 BUD: 10/20/2015
- 20152606@2 BUD: 12/22/2015
- 20152907@16 BUD: 1/23/2016
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 59 recalled by US Compounding Inc 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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