The Recall Desk
SevereFDA (Drugs)·D-668-2013·Announced 2013-07-10

Clinical Specialties Compounding Pharmacy Recalls Testosterone and Estradiol Injection

Clinical Specialties Compounding Pharmacy is recalling a specific lot of Test cyp 25 mg-Estradiol cyp 5 mg/ml injection due to 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 and involves a lack of assurance of sterility in an injectable drug, which poses a significant risk of serious injury or death from infection, meeting the criteria for a Severe rating.

Plain-English summary

Clinical Specialties Compounding Pharmacy is recalling 4ml vials of Test cyp 25 mg-Estradiol cyp 5 mg/ml injection. The recall affects lot number CABDBHAB:54 with an expiration date of 7/16/2013. The product was distributed in Florida, Georgia, and South Carolina.

The recall was initiated because FDA inspection findings resulted in concerns regarding quality control processes, specifically a lack of assurance of sterility. The agency has classified this recall as Class II.

Consumers who have this specific product should stop using it and contact their healthcare provider or the recalling firm for further instructions.

The recalled product

Product
Test cyp 25 mg-Estradiol cyp 5 mg/ml, Clinical Specialties Compounding Pharmacy, 318 Baston Road, Augusta, GA 30907
Affected units
4

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 CABDBHAB:54
  • Exp date: 7/16/2013

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 →