The Recall Desk
SevereFDA (Drugs)·D-670-2013·Announced 2013-07-10

Clinical Specialties Compounding Pharmacy Recalls Testosterone and Estradiol Injection

Clinical Specialties Compounding Pharmacy is recalling Test cyp 25 mg-estradiol cyp 7 mg/ml injections 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 medication, which poses a significant risk of serious injury or infection.

Plain-English summary

Clinical Specialties Compounding Pharmacy is recalling 12ml vials of Test cyp 25 mg-estradiol cyp 7 mg/ml. The recall is due to FDA inspection findings that raised concerns regarding quality control processes, specifically a lack of assurance of sterility.

The affected product is identified by Lot number CABCAFBC:67 and has an expiration date of 6/3/2013. 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 for further instructions.

The recalled product

Product
Test cyp 25 mg-estradiol cyp 7 mg/ml, Clinical Specialties Compounding Pharmacy, 318 Baston Road, Augusta, GA 30907
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 CABCAFBC:67
  • Exp date: 6/3/2013.

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 →