Olympia Pharmacy Recalls Diphenhydramine Injection Due to Sterility Concerns
Olympia Pharmacy is recalling Diphenhydramine 50 mg/ml Injection because FDA inspection findings 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 agency classification is FDA Class II. According to the rubric, FDA Class II recalls are typically scored as 4 (Severe), especially when involving sterility concerns in injectable medications which carry significant risk.
Plain-English summary
Lowlite Investments, Inc. D/B/A Olympia Pharmacy is recalling Diphenhydramine 50 mg/ml Injection. The product was compounded by Olympia Pharmacy in Orlando, FL. The recall affects one unit with code A3804 and an expiration date of 12/31/13.
The recall was initiated because FDA inspection findings resulted in concerns regarding quality control processes, specifically a lack of assurance of sterility. The distribution pattern for the recalled product was nationwide and Puerto Rico.
Consumers and healthcare providers should stop using the recalled product and contact Olympia Pharmacy for further instructions or a refund.
The recalled product
- Product
- Diphenhydramine 50 mg/ml Injection, compounded by Olympia Pharmacy, Orlando, FL
- Manufacturer
- Lowlite Investments, Inc. D/B/A Olympia Pharmacy
- Category
- Drug — Injectable
- 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)
- A3804 Exp 12/31/13
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.
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