The Recall Desk
SevereFDA (Drugs)·D-678-2013·Announced 2013-07-10

Clinical Specialties Compounding Pharmacy Recalls Testosterone and Estradiol Injection

Clinical Specialties Compounding Pharmacy is recalling 11ml vials of Test cyp 75 mg-estradiol cyp 5 mg/ml 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. According to the rubric, FDA Class II recalls involving significant risks such as lack of sterility in injectable drugs are categorized as Severe (Score 4).

Plain-English summary

Clinical Specialties Compounding Pharmacy is recalling 11ml vials of Test cyp 75 mg-estradiol cyp 5 mg/ml. The recall was initiated following FDA inspection findings that raised concerns regarding quality control processes and the lack of assurance of sterility for the product.

The affected product is identified by Lot number CABCAIBB:44 with an expiration date of 5/7/2013. 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 or the recalling firm for further instructions.

The recalled product

Product
Test cyp 75 mg-estradiol cyp 5 mg/ml, Clinical Specialties Compounding Pharmacy, 318 Baston Road, Augusta, GA 30907
Affected units
11

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 CABCAIBB:44
  • Exp date: 5/7/2013.

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 →