The Recall Desk
SevereFDA (Drugs)·D-760-2013·Announced 2013-07-17

Olympia Pharmacy Recalls MICC Injections Due to Sterility Concerns

Olympia Pharmacy is recalling MICC and MICC 25/50/330 injections 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, and the rubric specifies that FDA Class II recalls involving significant injury or structural defects are rated Severe. While no specific injuries are reported in the text, the lack of sterility assurance in an injectable drug represents a significant risk profile consistent with the Severe category for Class II drug recalls.

Plain-English summary

Lowlite Investments, Inc. D/B/A Olympia Pharmacy is recalling MICC (Methionine, Inositol, Choline, Cyanocobalamin, Chromium) Inj and MICC 25/50/330 Inj. The affected lots are L5306 (Exp 11/30/13), C5414 (Exp 9/21/13), and L5118 (Exp 12/31/13). The products were distributed nationwide and in Puerto Rico.

The recall was initiated following FDA inspection findings that resulted in concerns regarding quality control processes and the assurance of sterility for the compounded injections. The agency classification for this recall is Class II.

Consumers and healthcare providers should stop using the affected products and contact Olympia Pharmacy or their healthcare provider for further instructions.

The recalled product

Product
MICC (Methionine, Inositol, Choline, Cyanocobalamin, Chromium) Inj and MICC 25/50/330 Inj, compounded by Olympia Pharmacy, Orlando, FL
Affected units
3

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 →