The Recall Desk
SevereFDA (Drugs)·D-770-2013·Announced 2013-07-17

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.

What this means for you

Illness, injury, or structural failure has been reported. 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
Hazard
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.

See all 105 products in this recall →

Related recalls

Same manufacturer · Lowlite Investments, Inc. D/B/A Olympia Pharmacy

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Same hazard · sterility

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