The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-675-2013·Announced 2013-07-10

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

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

The agency’s classification

FDA (Drugs): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. 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. Per the rubric, FDA Class II recalls involving significant risks such as lack of sterility in injectable medications are categorized as Severe (Score 4), particularly when structural or process defects like quality control failures are cited.

Plain-English summary

Clinical Specialties Compounding Pharmacy is recalling Test Cyp 50 mg-estradiol cyp 2 mg/ml, a 13ml product. The recall affects Lot number CABCACBA:23 with an expiration date of 3/31/2013 and Lot number CABDAIAD:13 with an expiration date of 9/4/2013. The product was distributed in Florida, Georgia, and South Carolina.

The recall was initiated following FDA inspection findings that resulted in concerns regarding quality control processes. Specifically, the agency identified a lack of assurance of sterility for the affected product.

Consumers who have this product should stop using it 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
Manufacturer
Clinical Specialties Compounding Pharmacy
Category
Drug — Compounded Injectable
Hazard
Affected units
13

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 CABCACBA:23
  • Exp date: 3/31/2013 and Lot number CABDAIAD:13
  • Exp date: 9/4/2013.

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 →

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