The Recall Desk
SevereFDA (Drugs)·D-772-2013·Announced 2013-07-17

Olympia Pharmacy Recalls Phenylephrine Injection Due to Sterility Concerns

Olympia Pharmacy is recalling Phenylephrine 1 mg/ml Injection because FDA inspections raised concerns about quality control and sterility assurance.

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 source text explicitly identifies the agency classification as Class II. According to the severity rubric, an FDA Class II recall is assigned a score of 4 (Severe).

Plain-English summary

Lowlite Investments, Inc. D/B/A Olympia Pharmacy, located in Orlando, Florida, is recalling four units of Phenylephrine 1 mg/ml Injection. The product was distributed nationwide and to Puerto Rico. The specific lots affected are L5017 (Exp 10/31/13), C51301 (Exp 9/30/13), B5312 (Exp 8/31/13), and A5209 (Exp 11/01/13).

The recall was initiated following FDA inspection findings that resulted in concerns regarding the quality control processes used to ensure the sterility of the product. The agency classified this recall as Class II, indicating a situation where use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.

Consumers and healthcare providers who have purchased or possess these specific lots of Phenylephrine 1 mg/ml Injection should stop using the product and contact Olympia Pharmacy or their healthcare provider for instructions on how to return the product or obtain a replacement.

The recalled product

Product
Phenylephrine 1 mg/ml Injection, compounded by Olympia Pharmacy, Orlando, FL
Manufacturer
Lowlite Investments, Inc. D/B/A Olympia Pharmacy
Category
Drug — Injection
Hazard
Affected units
4

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 (4)

  • L5017 Exp 10/31/13
  • C51301 Exp 9/30/13
  • B5312 Exp 8/31/13
  • and A5209 Exp 11/01/13

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 concern

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