Agency classClass IIOur severity:Severe FDA (Drugs)·D-1641-2015·Announced 2015-09-23

Testosterone Cypionate Injection Recalled Due to Sterility Concerns

The Compounding Pharmacy of America is recalling Testosterone Cypionate 150 mg/ml Injection due to lack of assurance of sterility identified during an FDA inspection.

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 source text identifies an FDA Class II recall involving a sterile injection product where sterility assurance is compromised. Per the rubric, FDA Class II recalls involving significant injury/property-damage reports or structural defects (in this case, sterility failure of a sterile product) are classified as Severe (4).

Plain-English summary

The Compounding Pharmacy of America is recalling Testosterone Cypionate 150 mg/ml Injection Multi-Dose Vials. The recall was initiated because an FDA inspection identified Good Manufacturing Practice (GMP) violations that potentially impact product quality and sterility. The specific reason for the recall is a lack of assurance of sterility.

The affected product is distributed nationwide. The recall covers all lots distributed between November 2014 and May 2015. Specific lot codes and expiration dates listed in the recall include 03202015@1 (9/16/2015), 01192015@54 (7/18/2015), and 04082015@4 (10/5/2015).

Consumers and healthcare providers should stop using the recalled product and contact their healthcare provider or the recalling firm for further instructions. The FDA classifies this recall as Class II, indicating that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

The recalled product

Product: Testosterone Cypionate 150 mg/ml Injection Multi-Dose Vial, Sterile, Room Temperature, The Compounding Pharmacy of America, Knoxville, TN
Manufacturer: The Compounding Pharmacy of America
Category: Drug — Injectable Steroid
Hazard: sterility-failure
gmp-violation

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 (6)

All lots distributed between November 2014 and May 2015 03202015@1
9/16/2015
01192015@54
7/18/2015
04082015@4
10/5/2015

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 382 recalled by The Compounding Pharmacy of America 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 382 products in this recall →

Same manufacturer · The Compounding Pharmacy of America

See all →

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Methylcobalamin Injectable Recalled for Sterility Assurance Concerns
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Same hazard · sterility failure