Olympia Pharmacy Recalls Detomidine Injection Due to Sterility Concerns
Olympia Pharmacy is recalling two lots of Detomidine 10 mg/ml Injection because FDA inspection findings raised concerns about quality control and sterility assurance.
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. Per the rubric, FDA Class II recalls are assigned a score of 4 (Severe), particularly when involving critical quality control failures like sterility assurance in injectable medications.
Plain-English summary
Lowlite Investments, Inc. D/B/A Olympia Pharmacy is recalling two lots of Detomidine 10 mg/ml Injection. The affected lots are C5505 (expiration date 9/5/13) and C5107 (expiration date 9/7/13). The product was distributed nationwide and in Puerto Rico.
The recall was initiated following FDA inspection findings that resulted in concerns regarding quality control processes and the assurance of sterility for the compounded medication. The agency has classified this recall as Class II.
Consumers and healthcare providers should stop using the affected lots and contact Olympia Pharmacy for further instructions or a replacement.
The recalled product
- Product
- Detomidine 10 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)
- C5505 Exp 9/5/13 and C5107 Exp 9/7/13
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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