Why it was recalled
Marketed Without An Approved NDA/ANDA: FDA analysis found this product to contain undeclared sibutramine, phenolphthalein, and n-desmethyl sibutramine, making this an unapproved drug for which safety and efficacy have not been established and therefore, subject to recall.
Product description
A1 Slim, Dietary Supplement Beautifully Slim, capsule, 350 mg, 30-count bottle, A1 Slim LLC Pearland TX 77584, www.A1SLIM.COM, info@a1slim.com Bar-Code A105212014
Lot numbers, UPCs & expiration codes
All lots remaining within expiry.
Where it was sold
Nationwide.
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0058-2018
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Oct 6, 2017
- FDA report date
- Nov 8, 2017
- Quantity
- 700 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Kiriko, LLC.
Original FDA data
Every field from FDA enforcement report D-0058-2018, exactly as published.
Show all FDA fields
- City
- Manvel
- State
- TX
- Status
- Terminated
- Country
- United States
- Event ID
- 78235
- Address
- 3522 Ewing Dr
- Code information
- All lots remaining within expiry.
- Postal code
- 77578-3218
- Report date
- Nov 8, 2017
- Product type
- Drugs
- Recall number
- D-0058-2018
- Classification
- Class II
- Recalling firm
- Kiriko, LLC.
- Product quantity
- 700 bottles
- Termination date
- Sep 9, 2020
- Reason for recall
- Marketed Without An Approved NDA/ANDA: FDA analysis found this product to contain undeclared sibutramine, phenolphthalein, and n-desmethyl sibutramine, making this an unapproved drug for which safety and efficacy have not been established and therefore, subject to recall.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- A1 Slim, Dietary Supplement Beautifully Slim, capsule, 350 mg, 30-count bottle, A1 Slim LLC Pearland TX 77584, www.A1SLIM.COM, info@a1slim.com Bar-Code A105212014
- Distribution pattern
- Nationwide.
- Recall initiation date
- Oct 6, 2017
- Initial firm notification
- Press Release
- Center classification date
- Nov 1, 2017