MAC DADDY PURPLE Capsules Recalled for Undeclared Drug Ingredients
ABC Sales 1 Inc is recalling MAC DADDY PURPLE Capsules because they contain undeclared tadalafil and/or sildenafil, active ingredients in FDA-approved prescription drugs, making the product an unapproved drug.
The agency’s classification
FDA (Drugs): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
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 FDA classified this recall as Class I. The product is an undeclared unapproved drug containing pharmaceutical ingredients (tadalafil and/or sildenafil) that carry risks of serious adverse effects including cardiovascular complications, particularly in patients with underlying conditions or taking interacting medications. FDA Class I recalls are classified as Severe per the rubric.
Plain-English summary
MAC DADDY PURPLE Capsules, packaged in 10-count blisters per carton (ASIN B08Z63Z4QK, UPC 742137 605764), are being recalled by ABC Sales 1 Inc. The product was found to contain undeclared tadalafil and/or sildenafil, which are active ingredients in FDA-approved drugs used for male sexual enhancement. Because these ingredients are present without FDA approval and without proper labeling, the product is an unapproved drug.
The affected product was distributed nationwide in the USA via Amazon Marketplace. Approximately 336 cartons were distributed. The recalled lot is Lot # 1230005 with an expiration date of 03/30/2024.
Consumers who have purchased MAC DADDY PURPLE Capsules should stop use immediately. Anyone who has consumed this product and has questions or concerns should contact a healthcare provider.
The recalled product
- Product
- MAC DADDY PURPLE Capsules, packaged in 10-count blisters per carton, ASIN B08Z63Z4QK, UPC 742137 605764.
- Manufacturer
- ABC Sales 1 Inc
- Affected units
- 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 (2)
- Lot # 1230005
- Exp. date 03/30/2024
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 2 recalled by ABC Sales 1 Inc 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.
See all 2 products in this recall →Related recalls
Same manufacturer · ABC Sales 1 Inc
See all →- SevereMAC DADDY RED Capsules Recalled for Undeclared Drug Ingredients
FDA (Drugs) · 2022-02-23
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