The Recall Desk
SevereFDA (Drugs)·D-695-2013·Announced 2013-07-17

Olympia Pharmacy Recalls Alprostadil Due to Sterility Concerns

Olympia Pharmacy is recalling Alprostadil 2000 mcg/ml 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 recall is classified as FDA Class II. According to the rubric, FDA Class II recalls involving significant injury/property-damage reports or hospitalization are rated Severe (4). While specific injury reports are not detailed in the provided text, the agency's Class II classification for a sterility failure in a compounded drug aligns with the Severe tier criteria for significant risk.

Plain-English summary

Lowlite Investments, Inc. D/B/A Olympia Pharmacy is recalling five units of Alprostadil 2000 mcg/ml. 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 affected product was distributed nationwide and in Puerto Rico. Specific lot codes and expiration dates for the recalled units include B5008 (exp 12/31/13), K5030 (exp 11/30/13), A5716 (exp 8/31/13), C5121 (exp 9/12/13), and C5208 (exp 9/7/13).

Consumers who possess this medication should stop using it and contact their healthcare provider or the recalling firm for instructions on disposal or replacement.

The recalled product

Product
Alprostadil 2000 mcg/ml, compounded by Olympia Pharmacy, Orlando, FL
Manufacturer
Lowlite Investments, Inc. D/B/A Olympia Pharmacy
Category
Drug — Compounded Medication
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)

  • B5008 exp 12/31/13
  • K5030 Exp. 11/30/13
  • A5716 Exp. 8/31/13
  • C5121 Exp 9/12/13
  • and C5208 Exp 9/7/13

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 failure

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