The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-665-2013·Announced 2013-07-10

Clinical Specialties Compounding Pharmacy Recalls Test Cyp 100 mg/ml Due to Sterility Concerns

Clinical Specialties Compounding Pharmacy is recalling Test Cyp 100 mg/ml because FDA inspections raised concerns about quality control and sterility assurance.

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 sterility assurance failures in injectable drugs are categorized as Severe (Score 4), particularly when structural or process defects are identified by the agency.

Plain-English summary

Clinical Specialties Compounding Pharmacy is recalling Test Cyp 100 mg/ml. The recall was initiated following FDA inspection findings that resulted in concerns regarding the quality control processes and the assurance of sterility for the product.

The affected product is Test Cyp 100 mg/ml, manufactured by Clinical Specialties Compounding Pharmacy located in Augusta, Georgia. The total quantity involved in the recall is 219ml. The product was distributed in Florida, Georgia, and South Carolina.

Consumers who have this product should stop using it and contact their healthcare provider or the recalling firm for further instructions. The recall is classified as FDA Class II.

The recalled product

Product
Test Cyp 100 mg/ml, Clinical Specialties Compounding Pharmacy, 318 Baston Road, Augusta, GA 30907
Manufacturer
Clinical Specialties Compounding Pharmacy
Category
Drug — Injectable Steroid
Hazard
Affected units
219

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 CABCBFBA:15
  • Exp date: 4/13/2013
  • Lot number CABCACBA:58
  • Exp date: 3/31/2013
  • Lot number CABCAHBB:54
  • Exp date: 5/6/2013
  • Lot number CABCCHBB:63
  • Exp date: 5/26/2013
  • Lot number CABCAFBC:31
  • Exp date: 6/3/2013
  • Lot number CABCCHBS:23
  • Exp date: 6/25/2013
  • Lot number CABDBAAB:64
  • Exp date: 7/9/2013
  • Lot number CABDAIAB:59
  • Exp date: 7/7/2013
  • Lot number CABDAFAC:48
  • Exp date: 8/4/2013
  • Lot number CABDBJAC:27
  • Exp date: 8/18/2013 and Lot number CABDABAD:61

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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