The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-677-2013·Announced 2013-07-10

Clinical Specialties Compounding Pharmacy Recalls Test Cyp 50 mg-estradiol Blend

Clinical Specialties Compounding Pharmacy is recalling Test Cyp 50 mg-estradiol blend 22 mg due to 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. According to the rubric, FDA Class II recalls involving significant injury/property-damage reports or structural defects are rated Severe (4). While no specific injuries are reported in the text, the 'lack of assurance of sterility' in a compounded drug represents a significant risk of serious harm (infection), aligning with the Severe classification for Class II recalls with potential for significant harm.

Plain-English summary

Clinical Specialties Compounding Pharmacy is recalling Test Cyp 50 mg-estradiol blend 22 mg, a 13ml total quantity product. The recall was initiated following FDA inspection findings that raised concerns regarding quality control processes, specifically resulting in a lack of assurance of sterility.

The affected products were distributed in Florida, Georgia, and South Carolina. The recall includes three specific lots: Lot number CABCAIBA:36 with an expiration date of 4/6/2013; Lot number CABDDAAB:10 with an expiration date of 7/29/2013; and Lot number CABDAIAD:01 with an expiration date of 9/4/2013.

Consumers who possess these specific lots of the product should stop using them and contact their healthcare provider or the recalling firm for further instructions.

The recalled product

Product
Test Cyp 50 mg-estradiol blend 22 mg, Clinical Specialties Compounding Pharmacy, 318 Baston Road, Augusta, GA 30907
Manufacturer
Clinical Specialties Compounding Pharmacy
Category
Drug — Compounded Medication
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 (4)

  • Lot number CABCAIBA:36
  • Exp date: 4/6/2013
  • Lot number CABDDAAB:10
  • Exp date: 7/29/2013 and Lot number CABDAIAD:01 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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