Active recall · Unapproved ingredientUpdated · 1 yr 11 mo ago
Boulla LLC recall: Marketed as Dietary Supplement
FOR IMMEDIATE RELEASE – 11/04/24 – Sacramento, CA, Boulla LLC is voluntarily recalling lot YZM240406, Exp 04/05/27, of ZoomMax Capsules and ZapMax Capsules packaged in 10-count blisters in a cardboard carton to the consumer level. The products were found to be tainted with sildenafil via testing by the FDA, an ingredient in FDA approved products for treatment of male erectile dysfunction in the family of drugs known as phosphodiesterase (PDE-5) inhibitors and diclofenac, an FDA approved drug known as a nonsteroidal anti-inflammatory drug (NSAID) used to treat pain and inflammation. Products containing sildenafil and diclofenac cannot be marketed as dietary supplements. ZoomMax and ZapMax capsules are unapproved new drugs for which safety and efficacy have not been established and, therefore, subject to recall.
What to do
Boulla LLC is notifying its distributors and customers by this press announcement and is arranging for return of all recalled products by using the return product option on the Amazon platform. Consumers that have ZoomMax or ZapMax capsules lot number YZM240406 should stop using the product. Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product.
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Check your pack’s codes and dates against this recall.
Which products
Marketed as Dietary Supplement
- Producer
- Boulla LLC
- Brand
- Boulla LLC
Marketed as Dietary Supplement
- Producer
- Boulla LLC
- Brand
- Boulla LLC
- Lot code
- YZM240406
- Dates on pack
- FOR IMMEDIATE RELEASE – 11/04/24 – Sacramento, CA, Boulla LLC is voluntarily recalling lot YZM240406, Exp 04/05/27, of ZoomMax Capsules and ZapMax Capsules packaged in 10-count blisters in a cardboard carton to the consumer level. The products were found to be tainted with sildenafil via testing by the FDA, an ingredient in FDA approved products for treatment of male erectile dysfunction in the family of drugs known as phosphodiesterase (PDE-5) inhibitors and diclofenac, an FDA approved drug kno
Marketed as Dietary Supplement
- Producer
- Boulla LLC
- Brand
- Boulla LLC
- Lot code
- 04/05/27
- Dates on pack
- FOR IMMEDIATE RELEASE – 11/04/24 – Sacramento, CA, Boulla LLC is voluntarily recalling lot YZM240406, Exp 04/05/27, of ZoomMax Capsules and ZapMax Capsules packaged in 10-count blisters in a cardboard carton to the consumer level. The products were found to be tainted with sildenafil via testing by the FDA, an ingredient in FDA approved products for treatment of male erectile dysfunction in the family of drugs known as phosphodiesterase (PDE-5) inhibitors and diclofenac, an FDA approved drug kno