The Recall Desk
SevereFDA (Drugs)·D-788-2013·Announced 2013-07-17

Olympia Pharmacy Recalls Tripelennamine Injection Due to Sterility Concerns

Olympia Pharmacy is recalling two lots of compounded Tripelennamine 20 mg/ml Injection due to FDA inspection findings regarding 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 recall is classified as FDA Class II and involves a lack of assurance of sterility in an injectable medication, which poses a risk of serious adverse health consequences such as infection.

Plain-English summary

Lowlite Investments, Inc. D/B/A Olympia Pharmacy is recalling two lots of Tripelennamine 20 mg/ml Injection. The affected products were compounded by Olympia Pharmacy in Orlando, FL, and distributed nationwide and to Puerto Rico. The specific lots involved are B5620 (expiration date 8/20/13) and A0322 (expiration date 12/31/13).

The recall was initiated following FDA inspection findings that raised concerns regarding the quality control processes used to ensure the sterility of the compounded medication. The agency has classified this recall as Class II, indicating a situation where use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.

Consumers and healthcare providers who have purchased or received these specific lots of Tripelennamine 20 mg/ml Injection should stop using the product and contact their pharmacist or the recalling firm for instructions on return or disposal.

The recalled product

Product
Tripelennamine 20 mg/ml Injection, compounded by Olympia Pharmacy, Orlando, FL
Manufacturer
Lowlite Investments, Inc. D/B/A Olympia Pharmacy
Category
Drug — Compounded Injectable
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)

  • B5620 Exp 8/20/13 and A0322 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 →

Related recalls

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

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Same hazard · sterility

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