The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-756-2013·Announced 2013-07-17

Olympia Pharmacy Recalls Methylcobalamin and Folic Acid Injection Due to Sterility Concerns

Olympia Pharmacy is recalling Methylcobalamin and Folic Acid Injection due to FDA inspection findings regarding 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 recall is classified as FDA Class II. Per the rubric, FDA Class II recalls involving significant risks such as sterility assurance issues in injectable drugs are categorized as Severe.

Plain-English summary

Lowlite Investments, Inc. D/B/A Olympia Pharmacy is recalling Methylcobalamin 1 mg/ml / Folic Acid 2.5 mg/ml Injection. The recall was initiated following FDA inspection findings that raised concerns regarding quality control processes and the assurance of sterility for the product.

The affected product is identified by code L3326 with an expiration date of 6/30/13. The recall is classified as Class II by the FDA. Distribution was nationwide and in Puerto Rico.

Consumers should stop using the recalled product and contact their healthcare provider or the pharmacy for further instructions.

The recalled product

Product
Methylcobalamin 1 mg/ml / Folic Acid 2.5 mg/ml Injection, compounded by Olympia Pharmacy, Orlando, FL
Manufacturer
Lowlite Investments, Inc. D/B/A Olympia Pharmacy
Category
Drug — 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)

  • L3326 Exp 6/30/13

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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