The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-790-2013·Announced 2013-07-17

Olympia Pharmacy Recalls Vitamin A/D3/E Olive Oil Injection Due to Sterility Concerns

Olympia Pharmacy is recalling Vitamin A/D3/E Olive Oil 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 is assigned a score of 4 (Severe), as the rule states that if the agency's own classification is FDA Class I or II, the score must not be lower than 4.

Plain-English summary

Lowlite Investments, Inc. D/B/A Olympia Pharmacy is recalling one unit of Vitamin A/D3/E Olive Oil Injection. The product was compounded by Olympia Pharmacy in Orlando, Florida, and distributed nationwide and to Puerto Rico. The specific lot code is L5303 with an expiration date of 11/30/13.

The recall was initiated following FDA inspection findings that resulted in concerns regarding quality control processes and the assurance of sterility for the product. The agency has classified this recall as Class II.

Consumers who possess this specific product should stop using it and contact Olympia Pharmacy or their healthcare provider for instructions on how to return or dispose of the medication.

The recalled product

Product
Vitamin A/D3/E Olive Oil Injection, compounded by Olympia Pharmacy, Orlando, FL
Manufacturer
Lowlite Investments, Inc. D/B/A Olympia Pharmacy
Category
Drug — Compounded Injectable
Hazard
Affected units
1

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)

  • L5303 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.

See all 105 products in this recall →

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