The Recall Desk
SevereFDA (Drugs)·D-752-2013·Announced 2013-07-17

Olympia Pharmacy Recalls Meloxicam Injection Due to Sterility Concerns

Olympia Pharmacy is recalling Meloxicam 5 mg/ml Injection because FDA inspections raised concerns about 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 identifies the agency classification as Class II. Per the rubric, FDA Class II recalls are assigned a severity score of 4 (Severe), particularly when involving sterility concerns in injectable medications which carry significant risk.

Plain-English summary

Lowlite Investments, Inc. D/B/A Olympia Pharmacy is recalling Meloxicam 5 mg/ml Injection. The recall was initiated following FDA inspection findings that resulted in concerns regarding quality control processes and the assurance of sterility for the product.

The affected product is Meloxicam 5 mg/ml Injection, compounded by Olympia Pharmacy in Orlando, FL. The recall covers two units with lot codes B5426 (Expiration 8/26/13) and A5110 (Expiration 12/1/13). The product was distributed nationwide and to Puerto Rico.

Consumers and healthcare providers should stop using the recalled product and contact Olympia Pharmacy or their healthcare provider for further instructions. The FDA has classified this recall as Class II, indicating that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.

The recalled product

Product
Meloxicam 5 mg/ml Injection, compounded by Olympia Pharmacy, Orlando, FL
Manufacturer
Lowlite Investments, Inc. D/B/A Olympia Pharmacy
Category
Drug — 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)

  • B5426 Exp 8/26/13 and A5110 Exp 12/1/13

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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