The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-673-2013·Announced 2013-07-10

Clinical Specialties Compounding Pharmacy Recalls Testosterone Cypionate Due to Sterility Concerns

Clinical Specialties Compounding Pharmacy is recalling 12ml vials of Test cyp 50 mg/ml due to FDA inspection findings regarding quality control and lack of assurance of sterility.

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 recall is classified as FDA Class II. According to the rubric, an FDA Class II recall involving a drug with sterility concerns (which implies a risk of infection or hospitalization) falls under the 'Severe' category, as it is not a Class I recall but involves significant health risks.

Plain-English summary

Clinical Specialties Compounding Pharmacy, located in Augusta, Georgia, is recalling 12ml vials of Test cyp 50 mg/ml. The specific lot number is CABCCHBB:81, with an expiration date of 5/26/2013. The product was distributed in Florida, Georgia, and South Carolina.

The recall was initiated following FDA inspection findings that raised concerns regarding the quality control processes used by the pharmacy. Specifically, the agency identified a lack of assurance of sterility for the product.

Consumers who have this specific lot of Test cyp 50 mg/ml should stop using it and contact their healthcare provider or the recalling firm for further instructions.

The recalled product

Product
Test cyp 50 mg/ml, Clinical Specialties Compounding Pharmacy, 318 Baston Road, Augusta, GA 30907
Manufacturer
Clinical Specialties Compounding Pharmacy
Category
Drug — Compounded Injectable
Hazard
Affected units
12

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 number CABCCHBB:81
  • Exp date: 5/26/2013.

Distribution

Distributed in 3 states:

Part of a larger recall action

This product is one of 49 recalled by Clinical Specialties Compounding Pharmacy 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 49 products in this recall →

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