The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-793-2013·Announced 2013-07-17

Olympia Pharmacy Recalls Vitamin B-Buildup Injection Due to Sterility Concerns

Olympia Pharmacy is recalling Vitamin B-Buildup 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 recall is classified as FDA Class II. According to the rubric, an FDA Class II recall with potential for adverse health consequences (such as sterility issues in an injectable drug) corresponds to a severity score of 4 (Severe), as it is not a Class I recall but involves significant quality control concerns.

Plain-English summary

Lowlite Investments, Inc. D/B/A Olympia Pharmacy, located in Orlando, Florida, is recalling one unit of Vitamin B-Buildup Injection. The product is identified by the code B0122 and has an expiration date of August 22, 2013. The recall was initiated due to FDA inspection findings that resulted in concerns regarding quality control processes and the assurance of sterility.

The recalled product was distributed nationwide and to Puerto Rico. The source text does not specify the number of units distributed or the specific locations within the distribution area where the product was sold.

Consumers who have this product should stop using it and contact their healthcare provider or the recalling firm for instructions on how to return or dispose of the medication. The recall is classified as FDA Class II, indicating that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.

The recalled product

Product
Vitamin B-Buildup 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)

  • B0122 Exp 8/22/13

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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