Medical Food Product Recalled for Potential Mold Contamination
enterade Advanced Oncology Formula is recalled due to potential mold development and spoilage. The recall affects 43,336 bottles distributed nationwide.
The agency’s classification
FDA (Food): 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 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II recall for potential mold contamination of a medical food product used by immunocompromised oncology patients. No illnesses or injuries have been reported, and the hazard is theoretical rather than confirmed, meeting the criterion for risk-of-harm products where injury has not yet been reported.
Plain-English summary
enterade Advanced Oncology Formula, Original Vanilla Flavor, is a medical food product manufactured by Entrinsic Health Solution Inc. The 8 FL OZ (237 mL) bottles are designed to help manage and maintain GI function in oncology patients under physician supervision. A total of 43,336 bottles are affected by this recall.
The FDA issued this recall because the product has the potential to develop mold and spoil. Specific lots with expiration dates from August 29, 2024, through September 12, 2024, are affected, including lots OEV24122, OEV24222, OEV24322, OEV24422, OEV24522, OEV24922, OEV25022, OEV25122, OEV25222, and OEV25522.
The affected product was distributed to consumers in all U.S. states. Patients and healthcare providers who have purchased this product should discontinue use and contact Entrinsic Health Solution Inc. or their healthcare provider with any questions or to report health concerns related to use of this product.
The recalled product
- Product
- enterade Advanced Oncology Formula; Original Vanilla Flavor; Medical Food; Helps manage and maintain GI function; 8 FL OZ (237 mL); Recommended Use: Use as directed by your doctor, enterade is a medical food for patients under the supervision of a physician; Refrigerate after…
- Manufacturer
- ENTRINSIC HEALTH SOLUTION INC
- Category
- Food — Medical Food
- Affected units
- 43,336
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 (10)
- Lot: OEV24122 and Exp: 8/29/24
- Lot: OEV24222 and Exp: 8/30/24
- Lot: OEV24322 and Exp: 8/31/24
- Lot: OEV24422 and Exp: 9/1/24
- Lot: OEV24522 and Exp: 9/2/24
- Lot: OEV24922 and Exp: 9/6/24
- Lot: OEV25022 and Exp: 9/7/24
- Lot: OEV25122 and Exp: 9/8/24
- Lot: OEV25222 and Exp: 9/9/24
- Lot: OEV25522 and Exp: 9/12/24
Distribution
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