The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-706-2013·Announced 2013-07-17

Olympia Pharmacy Recalls Bi Mix Due to Sterility Concerns

Olympia Pharmacy is recalling Bi Mix compounded in Orlando, FL, 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 recall is classified as FDA Class II. Per the rubric, FDA Class II recalls involving significant risks such as sterility failures in compounded drugs are categorized as Severe (Score 4), particularly when no specific hospitalization reports are cited to elevate it to Critical.

Plain-English summary

Lowlite Investments, Inc. D/B/A Olympia Pharmacy is recalling four units of Bi Mix compounded in Orlando, Florida. The recall was initiated following FDA inspection findings that raised concerns regarding the quality control processes used during the compounding of the product.

The specific hazard identified is a lack of assurance of sterility. The affected products were distributed nationwide and to Puerto Rico. The recall includes specific lot codes: A5028 (Exp 6/2/13), B5011 (Exp 6/1/13), C4112 (Exp 6/1/13), and C4208 (Exp 6/20/13).

Consumers who have purchased these specific lots of Bi Mix should stop using the product and contact their healthcare provider or the recalling firm for further instructions.

The recalled product

Product
Bi mix, compounded by Olympia Pharmacy, Orlando, FL
Manufacturer
Lowlite Investments, Inc. D/B/A Olympia Pharmacy
Category
Drug — Compounded Drug
Hazard
Affected units
4

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 (4)

  • A5028 Exp 6/2/13
  • B5011 exp 6/1/13
  • C4112 Exp 6/1/13
  • and C4208 Exp 6/20/13

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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