McGuff Compounding Pharmacy Recalls Lipoic Acid Injection Due to Particulate Matter
McGuff Compounding Pharmacy Services is recalling Lipoic Acid Injection vials because filmy or cloudy particulate matter was observed in the product.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves particulate matter without reported injuries or illnesses, fitting the criteria for a moderate severity recall.
Plain-English summary
McGuff Compounding Pharmacy Services, Inc. is recalling 146 vials of Lipoic Acid Injection (1,200 mg/30 mL) due to the presence of particulate matter. The recall involves sterile 30 mL multiple-dose vials that were dispensed nationwide in the United States.
The recall was initiated because filmy or cloudy particulate matter was observed in the vials. The affected product is identified by Lot # 18M0991, Preparation # 390-2678, and has a Beyond Usage Date of 06/15/2019.
Consumers who have this product should stop using it and contact their healthcare provider or the pharmacy for further instructions.
The recalled product
- Product
- Lipoic Acid Injection (aka Alpha Lipoic Acid or Thioctic Acid), 1,200 mg/30 mL (40 mg/mL) Sterile 30 mL Multiple Dose Vial, Rx Only, McGuff Compounding Pharmacy Services, Inc., Santa Ana, CA 92704
- Manufacturer
- McGuff Compounding Pharmacy Services, Inc.
- Category
- Drug — Injectable
- Hazard
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 (3)
- Lot #: 18M0991
- Preparation #: 390-2678
- Beyond Usage Date: 06/15/2019
Distribution
Distributed nationwide across the United States.
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