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.
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 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.
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