The Recall Desk
SevereFDA (Drugs)·D-737-2013·Announced 2013-07-17

Olympia Pharmacy Recalls Compounded Guanabenz Injection Due to Sterility Concerns

Olympia Pharmacy is recalling three vials of compounded Guanabenz 8 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 source text explicitly states the agency classification is Class II. Per the rubric, if the agency's own classification is FDA Class II, the score must be at least 4 (Severe).

Plain-English summary

Lowlite Investments, Inc. D/B/A Olympia Pharmacy, located in Orlando, Florida, is recalling three vials of Guanabenz 8 mg/ml Injection. The recall was initiated following FDA inspection findings that raised concerns regarding the quality control processes used to ensure the sterility of the compounded product.

The affected product was distributed nationwide and in Puerto Rico. The specific lots involved are C3621 (expiration date 9/21/13), L3618 (expiration date 10/31/13), and A0224 (expiration date 6/30/13). The agency has classified this recall as Class II.

Consumers and healthcare providers who possess these specific lots of Guanabenz 8 mg/ml Injection should stop using the product and contact Olympia Pharmacy or their healthcare provider for further instructions.

The recalled product

Product
Guanabenz 8 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
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)

  • C3621 Exp 9/21/13
  • L3618 Exp 10/31/13
  • and A0224 Exp 6/30/13

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 concern

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