Olympia Pharmacy Recalls Phentolamine Injection Due to Sterility Concerns
Olympia Pharmacy is recalling five vials of Phentolamine 20 mg/ml Injection because FDA inspection findings raised concerns about quality control processes and assurance of sterility.
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 agency classification is FDA Class II, and the hazard involves a lack of assurance of sterility in an injectable drug, which poses a significant risk of serious injury or infection.
Plain-English summary
Lowlite Investments, Inc. D/B/A Olympia Pharmacy, located in Orlando, Florida, is recalling five vials of Phentolamine 20 mg/ml Injection. The recall was initiated following FDA inspection findings that resulted in concerns regarding the quality control processes and the assurance of sterility for the product.
The affected product was distributed nationwide and to Puerto Rico. The specific lot codes and expiration dates involved in this recall are B31012 (Exp 8/31/13), B5102 (Exp 8/10/13), C5228 (Exp 9/22/13), B5012 (Exp 12/31/13), and C5111 (Exp 9/11/13).
Consumers and healthcare providers should stop using the affected product and contact Olympia Pharmacy or their healthcare provider for further instructions.
The recalled product
- Product
- Phentolamine 20 mg/ml Injection, compounded by Olympia Pharmacy, Orlando, FL
- Manufacturer
- Lowlite Investments, Inc. D/B/A Olympia Pharmacy
- Category
- Drug — Injectable
- Affected units
- 5
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 (5)
- B31012 Exp 8/31/13
- B5102 Exp 8/10/13
- C5228 Exp 9/22/13
- B5012 Exp 12/31/13
- and C5111 exp 9/11/13
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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