The Recall Desk
SevereFDA (Drugs)·D-674-2013·Announced 2013-07-10

Clinical Specialties Compounding Pharmacy Recalls Test Cyp 50 mg-estradiol cyp 2 mg/ml

Clinical Specialties Compounding Pharmacy is recalling Test Cyp 50 mg-estradiol cyp 2 mg/ml due to FDA inspection findings regarding quality control and lack of assurance of sterility.

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/property-damage reports or hospitalization are Severe. While no specific injuries are reported in the text, the lack of sterility assurance in a compounded drug is a significant risk factor that aligns with the Severe classification for Class II recalls with potential for serious harm.

Plain-English summary

Clinical Specialties Compounding Pharmacy is recalling Test Cyp 50 mg-estradiol cyp 2 mg/ml. The recall was initiated following FDA inspection findings that raised concerns regarding quality control processes and the lack of assurance of sterility.

The affected product is a 65ml total quantity. Specific lots involved are Lot number CABCACBB:31 with an expiration date of 10/28/2013, and Lot number CABDBGAB:74 with an expiration date of 1/11/2014. The product was distributed in Florida, Georgia, and South Carolina.

Consumers and healthcare providers should stop using the recalled product and contact their healthcare provider or the recalling firm for further instructions.

The recalled product

Product
Test Cyp 50 mg-estradiol cyp 2 mg/ml, Clinical Specialties Compounding Pharmacy, 318 Baston Road, Augusta, GA 30907
Affected units
65

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 (3)

  • Lot number CABCACBB:31
  • Exp date: 10/28/2013 and Lot number CABDBGAB:74
  • Exp date: 1/11/2014.

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 →