The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-666-2013·Announced 2013-07-10

Clinical Specialties Compounding Pharmacy Recalls Test Cyp 200 mg/ml Due to Sterility Concerns

Clinical Specialties Compounding Pharmacy is recalling Test Cyp 200 mg/ml because FDA inspections raised concerns about quality control and sterility assurance. The product was distributed in Florida, Georgia, and South Carolina.

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 agency classification is FDA Class II. According to the rubric, FDA Class II recalls are classified as Severe (Score 4), particularly when involving sterility concerns in injectable products which carry significant risk.

Plain-English summary

Clinical Specialties Compounding Pharmacy is recalling Test Cyp 200 mg/ml due to FDA inspection findings that resulted in concerns regarding quality control processes and the assurance of sterility. The recall involves specific lots of the product manufactured by the pharmacy located in Augusta, Georgia.

The affected product was distributed in Florida, Georgia, and South Carolina. The recall includes twelve specific lot numbers with expiration dates ranging from April 2013 to August 2013. Consumers and healthcare providers should check their inventory for these specific lot numbers.

Individuals who have used the recalled product should consult their healthcare provider if they have concerns about their health. The FDA classifies this recall as Class II, indicating a reasonable probability that the use of or exposure to the violative product may cause temporary or medically reversible adverse health consequences.

The recalled product

Product
Test Cyp 200 mg/ml, Clinical Specialties Compounding Pharmacy, 318 Baston Road, Augusta, GA 30907
Manufacturer
Clinical Specialties Compounding Pharmacy
Category
Drug — Compounded Injectable
Hazard

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 (20)

  • Lot number CABCBJBA:26
  • Exp date: 4/17/2013
  • Lot number CABCBEBB:55
  • Exp date: 5/13/2013
  • Lot number CABCBEBB:75
  • Lot number CABCCBBC:96
  • Exp date: 6/19/2013
  • Lot number CABCCHBC:80
  • Exp date: 6/25/2013
  • Lot number CABDAJAB:88
  • Exp date: 7/8/2013
  • Lot number CABDAEAB:41
  • Exp date: 7/3/2013
  • Lot number CABDBBAB:23
  • Exp date: 7/10/2013
  • Lot number CABDBHAB:14
  • Exp date: 7/16/2013
  • Lot number CABDCEAB:13
  • Exp date: 7/23/2013
  • Lot number CABDCFAB:33

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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