Downing Labs Recalls Phosphatidylcholine Injection Due to Sterility Concerns
Downing Labs is recalling specific lots of Phosphatidylcholine/Deoxycholic Acid Injection because the company cannot assure the product's 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 with potential for adverse health consequences (such as sterility failures in injectable drugs) are categorized as Severe.
Plain-English summary
Downing Labs, LLC is recalling 2,189 vials of Phosphatidylcholine/Deoxycholic Acid Injection (Preserved) in 50 mL vials. The affected concentrations are 10/4.75%, 5/2.5%, and 5/4.2%. The recall is being conducted because the manufacturer lacks assurance of the product's sterility.
The affected product was distributed nationwide in the United States as well as in Australia, Brazil, the Bahamas, Switzerland, France, Colombia, Hong Kong, Indonesia, India, Japan, Malaysia, New Zealand, the Philippines, Singapore, Thailand, Trinidad and Tobago, and Taiwan. All lots of the specified products are included in this recall.
Consumers and healthcare providers should stop using the recalled product and contact their healthcare provider or the manufacturer for further instructions. The FDA has classified this recall as Class II, indicating that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.
The recalled product
- Product
- Phosphatidylcholine/Deoxycholic Acid Injection (Preserved) 50 ML 10/4.75%; Phosphatidylcholine/Deoxycholic Acid Injection (Preserved) 50 ML 5/2.5%; Phosphatidylcholine/Deoxycholic Acid Injection (Preserved) 50 ML 5/4.2%, Rx only, Downing Labs, LLC 4001 McEwen Rd, Suite 110…
- Manufacturer
- Downing Labs, LLC
- Category
- Drug — Injectable
- Affected units
- 2,189
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)
- All lots
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 48 recalled by Downing Labs, LLC 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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