Class I
Terminated
RISE UP RED EDITION Capsules, 650 mg, 10-count blisters packaged in a carton, ASIN B08JCWG84D, barcode X002NI8PE1.
This recall has been terminated (originally issued March 2, 2022).
- Company
- Positive Health
- Recall Initiated
- February 10, 2022
- Posted
- March 2, 2022
- Recall Number
- D-0645-2022
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 5,500 cartons
- Firm Location
- Wilmington, DE, United States
- Official Source
- View on FDA website ↗
Reason for Recall
Marketed Without An Approved NDA/ANDA: Product was found to contain undeclared tadalafil, an ingredient found in FDA approved products for the treatment of male sexual enhancement, making this an unapproved drug.
Distribution
Product was distributed nationwide via the internet through Amazon Marketplace.
Lot / Code Info
Lot # 48658908, Exp. date 09/09/2023
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