The Recall Desk
SevereFDA (Drugs)·D-739-2013·Announced 2013-07-17

Olympia Pharmacy Recalls HACC 270.1 Injection Due to Sterility Concerns

Olympia Pharmacy is recalling HACC 270.1 Injection because FDA inspection findings raised concerns about quality control processes and the assurance of sterility.

What this means for you

Illness, injury, or structural failure has been reported. 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 safety concerns such as lack of sterility assurance are categorized as Severe.

Plain-English summary

Lowlite Investments, Inc. D/B/A Olympia Pharmacy, located in Orlando, Florida, is recalling HACC 270.1 Injection. The recall was initiated following FDA inspection findings that resulted in concerns regarding the quality control processes used to ensure the sterility of the product.

The affected product consists of 2 units of HACC 270.1 Injection. The specific lot codes involved are C0321 with an expiration date of 9/3/13 and B5627 with an expiration date of 6/4/13. The product was distributed nationwide and to Puerto Rico.

Consumers who have this product should stop using it and contact their healthcare provider or the recalling firm for further instructions. This recall is classified as Class II by the FDA.

The recalled product

Product
HACC 270.1 Injection, compounded by Olympia Pharmacy, Orlando, FL
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)

  • C0321 Exp 9/3/13 and B5627 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 →