Olympia Pharmacy Recalls Deslorelin Vials Due to Sterility Concerns
Olympia Pharmacy is recalling two vials of compounded Deslorelin 15 mg due to FDA inspection findings regarding quality control and lack of assurance of sterility.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II and involves a risk-of-harm product (sterility concerns) where injury has not yet been reported, fitting the 'High' severity criteria.
Plain-English summary
Lowlite Investments, Inc. D/B/A Olympia Pharmacy is recalling two vials of Deslorelin 15 mg compounded in Orlando, Florida. The recall was initiated following FDA inspection findings that raised concerns regarding the company's quality control processes and the lack of assurance of sterility for the product.
The affected products are identified by lot codes A3021 (expiration date 6/2/13) and L5011 (expiration date 12/11/13). The recall is classified as FDA Class II. The products were distributed nationwide and to Puerto Rico.
Consumers who have these specific vials should stop using them and contact their healthcare provider or the pharmacy for further instructions. The source text does not report any specific illnesses or injuries associated with this recall.
The recalled product
- Product
- Deslorelin 15 mg vial, compounded by Olympia Pharmacy, Orlando, FL
- Manufacturer
- Lowlite Investments, Inc. D/B/A Olympia Pharmacy
- Category
- Drug — Compounded Medication
- 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)
- A3021 Exp 6/2/13 and L5011 exp 12/11/13
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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