The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-757-2013·Announced 2013-07-17

Olympia Pharmacy Recalls Methylcobalamin Injections Due to Sterility Concerns

Olympia Pharmacy is recalling two lots of compounded Methylcobalamin injections nationwide and in Puerto Rico due to FDA inspection findings regarding quality control and lack of assurance of sterility.

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, FDA Class II recalls are assigned a score of 4 (Severe), particularly when involving significant risks such as sterility assurance in injectable medications.

Plain-English summary

Lowlite Investments, Inc. D/B/A Olympia Pharmacy, located in Orlando, Florida, is recalling two lots of compounded Methylcobalamin injections. The affected products are Methylcobalamin 25 mg/ml Injection (Lot L3620, Exp 12/31/13) and Methylcobalamin 5000 mcg/ml Injection (Lot A3328, Exp 6/28/13). These products were distributed nationwide and in Puerto Rico.

The recall was initiated following FDA inspection findings that raised concerns regarding the quality control processes used by the pharmacy. Specifically, the agency identified a lack of assurance of sterility for the compounded products. The FDA has classified this recall as Class II.

Consumers and healthcare providers who have these specific lots of Methylcobalamin injections should stop using them and contact Olympia Pharmacy or their healthcare provider for instructions on return or disposal. No specific illnesses or injuries have been reported in the source text.

The recalled product

Product
Methylcobalamin 25 mg/ml Inj and 5000 mcg/ml Injection, compounded by Olympia Pharmacy, Orlando, FL
Manufacturer
Lowlite Investments, Inc. D/B/A Olympia Pharmacy
Category
Drug — Compounded Injectable
Hazard
Affected units
2

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)

  • 25mg/ml Inj Lot L3620 Exp 12/31/13 5000mcg/ml Inj Lot A3328 Exp 6/28/13

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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