Olympia Pharmacy Recalls Hippiron Injection Due to Sterility Concerns
Olympia Pharmacy is recalling two lots of Hippiron 20 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 explicitly identifies the agency classification as Class II. According to the severity rubric, an FDA Class II recall must be assigned a score of 4 (Severe) and cannot be scored lower.
Plain-English summary
Lowlite Investments, Inc. D/B/A Olympia Pharmacy is recalling two lots of Hippiron 20 mg/ml Injection. The affected lots are B5006 (expiration date 8/6/13) and L5807 (expiration date 11/30/13). The product was distributed nationwide and to 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 who have these specific lots of Hippiron 20 mg/ml Injection should stop using the product and contact their healthcare provider or the recalling pharmacy for further instructions.
The recalled product
- Product
- Hippiron 20 mg/ml Injection, compounded by Olympia Pharmacy, Orlando, FL
- Manufacturer
- Lowlite Investments, Inc. D/B/A Olympia Pharmacy
- Category
- Drug — Compounded Injection
- 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)
- B5006 Exp 8/6/13 and L5807 Exp 11/30/13
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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