The Recall Desk
SevereFDA (Drugs)·D-702-2013·Announced 2013-07-17

Olympia Pharmacy Recalls Atropine Sulfate Injection Due to Sterility Concerns

Olympia Pharmacy is recalling Atropine Sulfate 50 mg/ml Injection due to FDA inspection findings regarding quality control and lack of assurance of sterility.

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. According to the rubric, an FDA Class II recall involving a significant hazard such as lack of sterility in an injectable drug corresponds to a Severe (4) rating.

Plain-English summary

Lowlite Investments, Inc. D/B/A Olympia Pharmacy is recalling Atropine Sulfate 50 mg/ml Injection. The recall was initiated following FDA inspection findings that raised concerns regarding the quality control processes used during the compounding of the product.

The specific hazard identified is a lack of assurance of sterility. The affected product is identified by the code C5115 with an expiration date of 9/11/13. The recall number is D-702-2013.

The product was distributed nationwide and in Puerto Rico. Consumers and healthcare providers should stop using the recalled product and contact their pharmacist or the recalling firm for further instructions.

The recalled product

Product
Atropine Sulfate 50 mg/ml Injection, compounded by Olympia Pharmacy, Orlando, FL
Manufacturer
Lowlite Investments, Inc. D/B/A Olympia Pharmacy
Category
Drug — Injectable
Hazard
Affected units
1

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)

  • C5115 Exp 9/11/13

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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