The Recall Desk
SevereFDA (Drugs)·D-733-2013·Announced 2013-07-17

Olympia Pharmacy Recalls Gentamicin Injection Due to Sterility Concerns

Olympia Pharmacy is recalling two lots of Gentamicin 300 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 identifies the agency classification as Class II. According to the severity rubric, FDA Class II recalls are assigned a score of 4 (Severe), particularly when involving critical quality control failures like sterility assurance in injectable drugs.

Plain-English summary

Lowlite Investments, Inc. D/B/A Olympia Pharmacy is recalling two lots of Gentamicin 300 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 product.

The affected lots are identified by codes B5014 (expiration date 8/13/13) and C3913 (expiration date 9/9/13). The product was distributed nationwide and in Puerto Rico.

Consumers and healthcare providers should stop using the recalled product and contact their pharmacist or the recalling firm 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
Gentamicin 300 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)

  • B5014 Exp 8/13/13 and C3913 Exp 9/9/13

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

See all →

Same hazard · sterility

See all →