The Recall Desk
SevereFDA (Drugs)·D-786-2013·Announced 2013-07-17

Olympia Pharmacy Recalls Testosterone Cypionate Injection Due to Sterility Concerns

Olympia Pharmacy is recalling Testosterone Cypionate injections because FDA inspection findings raised concerns about quality control and sterility assurance.

What this means for you

Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The agency classification is FDA Class II. Per the rubric, FDA Class II recalls are assigned a score of 4 (Severe), particularly when involving sterility concerns in injectable products which carry significant risk of adverse health consequences.

Plain-English summary

Lowlite Investments, Inc. D/B/A Olympia Pharmacy is recalling Testosterone Cypionate (100 mg/ml & 200 mg/ml) Injection. The recall was initiated following FDA inspection findings that resulted in concerns regarding quality control processes and the assurance of sterility for the product.

The affected product was compounded by Olympia Pharmacy in Orlando, FL, and distributed nationwide and to Puerto Rico. The specific codes associated with the recall are A5016 (Expiration 12/31/13) and B5028 (Date 6/5/13).

Consumers who have this product should stop using it and contact their healthcare provider or the pharmacy for further instructions. The FDA has classified this recall as Class II, indicating that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.

The recalled product

Product
Testosterone Cypionate (100 mg/ml & 200 mg/ml) Injection, compounded by Olympia Pharmacy, Orlando, FL
Manufacturer
Lowlite Investments, Inc. D/B/A Olympia Pharmacy
Category
Drug — Injectable Steroid
Hazard
Affected units
2

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 (1)

  • A5016 Exp 12/31/13 and B5028 6/5/13

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 105 recalled by Lowlite Investments, Inc. D/B/A Olympia 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 105 products in this recall →

Related recalls

Same manufacturer · Lowlite Investments, Inc. D/B/A Olympia Pharmacy

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Same hazard · sterility

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