AnazaoHealth Recalls Compounded Plaquex Intravenous Injection Due to Unapproved Ingredient Source
AnazaoHealth Corporation is recalling 51 vials of Compounded Plaquex intravenous injection nationwide because the product contains an active pharmaceutical ingredient from an unapproved source.
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 source text explicitly identifies the agency classification as Class II. According to the severity rubric, FDA Class II recalls are assigned a score of 4 (Severe), particularly when involving structural or sourcing defects in pharmaceutical products.
Plain-English summary
AnazaoHealth Corporation is voluntarily recalling 51 vials of Compounded Plaquex, an intravenous injection, distributed nationwide. The product is a 50 ML vial containing Phosphatidyl Choline, Sodium Deoxycholate, Benzyl Alcohol, Ethanol, and di Alpha Tocopheryl Acetate in Sterile Water for injection.
The recall was initiated due to Good Manufacturing Practices deviations. Specifically, the product contains an active pharmaceutical ingredient from an unapproved source. The affected lots are 112614-1MC-82186, 112614-1MC-82187, 112614-1MC-82188, and 112614-1MC-82189, all with expiration dates of May 26, 2015.
The U.S. Food and Drug Administration has classified this recall as Class II. Consumers and healthcare providers should stop using the affected product and contact AnazaoHealth Corporation for further instructions or a refund.
The recalled product
- Product
- Compounded Plaquex, intravenous injection, 50 ML vial. Each ml contains: Phosphatidyl Choline 50 mg, Sodium Deoxycholate 25 mg, Benzyl Alcohol 0.9%, Ethanol (95%) 2.4 mg di Alpha Tocopheryl Acetate 0.2 mg in Sterile Water for injection.
- Manufacturer
- AnazaoHealth Corporation
- Category
- Drug — Compounded Injectable
- Affected units
- 51
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)
- Lot #: 112614-1MC-82186 Exp 5/26/2015
- 112614-1MC-82187 Exp 5/26/2015
- 112614-1MC-82188 Exp 05/26/205
- 112614-1MC-82189 Exp 5/26/2015
Distribution
Distributed nationwide across the United States.
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