The Recall Desk
HighFDA (Drugs)·D-671-2013·Announced 2013-07-10

Clinical Specialties Compounding Pharmacy Recalls Test Cyp 25 mg-e(2) Blend

Clinical Specialties Compounding Pharmacy is recalling Test Cyp 25 mg-e(2) blend 12 mg/ml due to FDA inspection findings regarding quality control and lack of assurance of sterility.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves a lack of assurance of sterility in a drug product, which poses a risk of harm without reported illnesses, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.

Plain-English summary

Clinical Specialties Compounding Pharmacy is recalling Test Cyp 25 mg-e(2) blend 12 mg/ml, 8ml vials. The recall was initiated following FDA inspection findings that raised concerns regarding the quality control processes used during manufacturing.

The specific product affected is identified by Lot number CABCCHBB:03 with an expiration date of 5/26/2013. The product was distributed in Florida, Georgia, and South Carolina.

The reason for the recall is a lack of assurance of sterility. Consumers and healthcare providers should stop using the affected product and contact their pharmacist or the recalling firm for further instructions.

The recalled product

Product
Test Cyp 25 mg-e(2) blend 12 mg/ml, Clinical Specialties Compounding Pharmacy, 318 Baston Road, Augusta, GA 30907
Affected units
8

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:03
  • 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 →