The Recall Desk
Agency classClass IIOur severity:HighFDA (Drugs)·D-758-2013·Announced 2013-07-17

Methylprednisolone Injection Is Recalled Over Sterility Assurance Concerns

Olympia Pharmacy is recalling compounded methylprednisolone acetate 80 mg/mL injection, code A3104, expiring June 4, 2013, because FDA inspection findings raised concerns about quality control and sterility assurance. The product was distributed nationwide and in Puerto Rico.

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 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall is FDA Class II, but the source does not report hospitalizations or injuries. The sterility concern presents a risk of harm, meeting the High criterion for a risk-of-harm product without reported injury.

Plain-English summary

Lowlite Investments, Inc. d/b/a Olympia Pharmacy is recalling compounded methylprednisolone acetate 80 mg/mL injection. The recalled product is identified as code A3104, with an expiration date of June 4, 2013.

FDA inspection findings raised concerns about the firm's quality control processes and lack of assurance that the injection was sterile.

The product was distributed nationwide and in Puerto Rico. Consumers who have this product should not use it and should contact their pharmacist or healthcare provider for guidance.

The recalled product

Product
Methylprednisolone Acetate 80 mg/ml Injection, compounded by Olympia, FL
Manufacturer
Lowlite Investments, Inc. D/B/A Olympia Pharmacy
Category
Drug — Compounded Injection
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)

  • A3104 Exp 6/4/13

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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