The Recall Desk
SevereFDA (Drugs)·D-700-2013·Announced 2013-07-17

Olympia Pharmacy Recalls Aminophylline Injection Due to Sterility Concerns

Olympia Pharmacy is recalling Aminophylline 2.5% Injection because FDA inspection findings raised concerns about quality control processes and 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, and the hazard involves a lack of assurance of sterility in an injectable medication, which carries a significant risk of serious injury or infection.

Plain-English summary

Lowlite Investments, Inc. D/B/A Olympia Pharmacy is recalling one unit of Aminophylline 2.5% Injection. The product was compounded by Olympia Pharmacy in Orlando, Florida, and distributed nationwide and to Puerto Rico. The specific lot code is A5630 with an expiration date of 12/31/13.

The recall was initiated due to a lack of assurance of sterility. FDA inspection findings resulted in concerns regarding the quality control processes used during the compounding of the medication.

Consumers who possess this specific product should stop using it and contact their healthcare provider or the recalling firm for further instructions.

The recalled product

Product
Aminophylline 2.5% Injection, compounded by Olympia Pharmacy, Orlando, FL
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)

  • A5630 Exp. 12/31/13

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 →