The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-783-2013·Announced 2013-07-17

Olympia Pharmacy Recalls Stanozolol Injection Due to Sterility Concerns

Olympia Pharmacy is recalling Stanozolol injections 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. According to the rubric, FDA Class II recalls with potential for adverse health consequences (such as sterility issues in injectable drugs) are categorized as Severe (Score 4), as they are not Class I but involve significant risk.

Plain-English summary

Lowlite Investments, Inc. D/B/A Olympia Pharmacy is recalling Stanozolol (50 mg/ml and 100 mg/ml) Injection. The recall was initiated after FDA inspection findings 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. The recall covers three specific lots: Lot B5727 (50 mg/ml, expiration 8/27/13), Lot C5708 (50 mg/ml, expiration 9/8/13), and Lot C5706 (100 mg/ml, expiration 9/6/13). The product was distributed nationwide and in Puerto Rico.

Consumers should stop using the recalled Stanozolol injections 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
Stanozolol (50 mg/ml and 100 mg/ml) Injection, compounded by Olympia Pharmacy, Orlando, FL
Manufacturer
Lowlite Investments, Inc. D/B/A Olympia Pharmacy
Category
Drug — Injectable
Hazard
Affected units
3

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 (3)

  • 50mg/ml = Lots B5727 Exp 8/27/13
  • and C5708 Exp 9/8/13 // 100
  • g/ml =Lot C5706 Exp 9/6/13

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 →

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