The Recall Desk
SevereFDA (Drugs)·D-713-2013·Announced 2013-07-17

Olympia Pharmacy Recalls Chlorpromazine Injection Due to Sterility Concerns

Olympia Pharmacy is recalling two lots of compounded Chlorpromazine HCL 100 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 recall is classified as FDA Class II and involves a lack of assurance of sterility in an injectable medication, which poses a significant risk of serious injury or adverse health consequences.

Plain-English summary

Lowlite Investments, Inc. D/B/A Olympia Pharmacy, located in Orlando, Florida, is recalling two lots of Chlorpromazine HCL 100 mg/ml Injection. The affected products were compounded by Olympia Pharmacy and distributed nationwide and to Puerto Rico. The specific lot codes are C5812 (expiration date 9/8/13) and L4317 (expiration date 6/30/13).

The recall was initiated following FDA inspection findings that raised concerns regarding the quality control processes used during compounding. Specifically, the inspection identified a lack of assurance of sterility for the product. The agency has classified this recall as Class II.

Consumers and healthcare providers who have these specific lots of Chlorpromazine HCL 100 mg/ml Injection should stop using them and contact Olympia Pharmacy or their healthcare provider for further instructions.

The recalled product

Product
Chlorpromazine HCL 100 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)

  • C5812 Exp 9/8/13 and L4317 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

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