The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-1260-2019·Announced 2019-05-08

Customceutical Compounding Recalls Test PROCYP Injectable Due to Sterility Concerns

Customceutical Compounding is recalling Test PROCYP injectable vials because the company cannot guarantee the product is sterile.

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 a lack of sterility assurance for an injectable product, which poses a significant risk of serious injury or infection. Per the rubric, significant injury reports or structural defects in high-risk products align with a Severe rating.

Plain-English summary

Customceutical Compounding is voluntarily recalling Test PROCYP (Testosterone Cypionate 200mg/ml and Testosterone Propionate 20mg/ml) 5 ml multidosed vials. The recall was initiated because the firm lacks assurance of sterility for these injectable solutions. The affected product is identified by Lot # 03112019@10 and has an expiration date of 6/19/19.

The recall covers products distributed nationwide in the United States. The FDA has classified this recall as Class II, indicating that use of the product could cause temporary or medically reversible health consequences.

Consumers who have this product should stop using it and contact Customceutical Compounding at 480 516 0272 for instructions on how to return the product or obtain a refund.

The recalled product

Product
Test PROCYP (TESTOSTERONE CYPIONATE 200MG/ML TESTOSTERONE PROPIONATE 20MG/ML), 5 ML MULTIDOSE VIAL INJ COMPOUNDED. Customceutical Compounding 4611 E. Shea Blvd. Bldg 3 180, Phoenix, AZ 85028 Ph. 480 516 0272
Manufacturer
Customceutical Compounding
Category
Drug — Injectable Sterile Solution
Hazard
Affected units
5

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 (2)

  • Lot #: 03112019@10
  • Exp 6/19/19

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 10 recalled by Customceutical Compounding 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 10 products in this recall →

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