Olympia Pharmacy Recalls ITPP and DMG Injection Due to Sterility Concerns
Olympia Pharmacy is recalling ITPP 50 mg/ml DMG 100 mg/ml Injection because FDA inspections raised concerns about quality control and sterility assurance.
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 agency classification is FDA Class II, which corresponds to a Severe rating under the rubric, particularly given the risk of infection associated with lack of sterility assurance in an injectable drug.
Plain-English summary
Lowlite Investments, Inc. D/B/A Olympia Pharmacy is recalling ITPP 50 mg/ml DMG 100 mg/ml Injection. The recall was initiated after FDA inspection findings resulted in concerns regarding quality control processes and the assurance of sterility for the product.
The affected product was compounded by Olympia Pharmacy in Orlando, FL. The recall covers two units of the injection with lot codes A3113 (expiration 7/1/13) and A3401 (expiration 2/1/14). 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 instructions on disposal or return.
The recalled product
- Product
- ITPP 50 mg/ml DMG 100 mg/ml Injection, compounded by Olympia Pharmacy, Orlando, FL
- Manufacturer
- Lowlite Investments, Inc. D/B/A Olympia Pharmacy
- Category
- Drug — Injectable
- 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)
- A3113 Exp 7/1/13 and A3401 Exp 2/1/14
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.
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