US Compounding Recalls Testosterone Cypionate Vials Due to Sterility Concerns
US Compounding Inc is recalling 2,524 vials of Testosterone cypionate, USP due to deficient practices that may impact 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 agency classified this as an FDA Class II recall. Per the rubric, FDA Class II recalls involving significant injury/property-damage reports or structural defects are rated Severe (4). While no specific injuries are reported in the text, the potential for serious harm from non-sterile injectable medications justifies the higher severity rating over a standard Class II.
Plain-English summary
US Compounding Inc is recalling 2,524 vials of Testosterone cypionate, USP (250 mg/mL), 10 mL Multi-Dose Vial, For Deep IM Injection Only. The product was compounded by US Compounding Pharmacy in Conway, Arkansas, and distributed nationwide.
The recall is being conducted 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 dates.
Consumers and healthcare providers should stop using the affected vials and contact their healthcare provider or the recalling firm for further instructions. The affected lot codes and best-use-by dates are listed in the official recall documentation.
The recalled product
- Product
- Testosterone cypionate, USP (250 mg/mL), 10 mL Multi-Dose Vial, For Deep IM Injection Only, Rx only, Compounded by US Compounding Pharmacy, Conway, Arkansas, 72653, NDC 62295-2131-07
- Manufacturer
- US Compounding Inc
- Affected units
- 2,524
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: 20150306@41 BUD: 11/30/2015
- 20150505@56 BUD: 11/1/2015
- 20150605@21 BUD: 11/2/2015
- 20151607@33 BUD: 1/12/2015
- 20152104@9 BUD: 10/18/2015
- 20152206@24 BUD: 12/19/2015
- 20151404@26 BUD: 10/11/2015
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.
See all 59 products in this recall →Related recalls
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