The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-762-2013·Announced 2013-07-17

Olympia Pharmacy Recalls Naproxen Injection Due to Sterility Concerns

Olympia Pharmacy is recalling Naproxen 100 mg/ml Injection due to FDA inspection findings regarding quality control and lack of assurance of sterility.

The agency’s classification

FDA (Drugs): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. 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 drug, which poses a risk of serious health consequences such as infection, meeting the criteria for a Severe rating.

Plain-English summary

Lowlite Investments, Inc. D/B/A Olympia Pharmacy is recalling Naproxen 100 mg/ml Injection. The recall was initiated following FDA inspection findings that raised concerns regarding the quality control processes used during compounding. Specifically, the agency identified a lack of assurance of sterility for the product.

The affected product is Naproxen 100 mg/ml Injection, compounded by Olympia Pharmacy in Orlando, FL. The specific lot code is K5013 with an expiration date of 11/30/13. The product was distributed nationwide and to Puerto Rico.

Consumers and healthcare providers should stop using the recalled product and contact their pharmacist or the recalling firm for further instructions. This recall is classified as FDA Class II.

The recalled product

Product
Naproxen 100 mg/ml Injection, compounded by Olympia Pharmacy, Orlando, FL
Manufacturer
Lowlite Investments, Inc. D/B/A Olympia Pharmacy
Category
Drug — Injectable
Hazard
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)

  • K5013 Exp 11/30/13

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 →

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