Over-the-counter & supplements recalls

Pyramids Wholesale Inc. — ALPHASTRIP MALE PERFORMANCE ENHANCER, The fastest acting sublingual, Serving Size (1 strip)

Marketed without an approved NDA/ANDA: Products found to contain undeclared sildenafil and/or tadalafil.

Why this is here: It was found to contain a drug or chemical that is not on the label. That is different from an allergen or a contamination scare: anyone taking it has been taking a substance nobody prescribed, in an unknown dose, and it can interact with medication they are already on. Follow the agency notice rather than judging it by how the product looks.

Pyramids Wholesale Inc. — The GOAT SUBLINGUAL STRIP, MALE ENHANCEMENT, 2 Pack

Marketed without an approved NDA/ANDA: Products found to contain undeclared sildenafil and/or tadalafil.

Why this is here: It was found to contain a drug or chemical that is not on the label. That is different from an allergen or a contamination scare: anyone taking it has been taking a substance nobody prescribed, in an unknown dose, and it can interact with medication they are already on. Follow the agency notice rather than judging it by how the product looks.

Pyramids Wholesale Inc. — Weiner Boner Honey, 12g packet, 100% Organic Formula.

Marketed without an approved NDA/ANDA: Products found to contain undeclared sildenafil and/or tadalafil.

Why this is here: It was found to contain a drug or chemical that is not on the label. That is different from an allergen or a contamination scare: anyone taking it has been taking a substance nobody prescribed, in an unknown dose, and it can interact with medication they are already on. Follow the agency notice rather than judging it by how the product looks.

Pyramids Wholesale Inc. — Pink Pussycat Honey, net wt: 20gx12 sachets, UPC 7 918750 046557

Marketed without an approved NDA/ANDA: Products found to contain undeclared sildenafil and/or tadalafil.

Why this is here: It was found to contain a drug or chemical that is not on the label. That is different from an allergen or a contamination scare: anyone taking it has been taking a substance nobody prescribed, in an unknown dose, and it can interact with medication they are already on. Follow the agency notice rather than judging it by how the product looks.

Optikem International, Inc. — TRP Natural Eyes Red Eye Relief, Sterile Eye Drops, Homeopathic, 0.33 FL OZ (10 mL)

Lack of Assurance of Sterility

Optikem International, Inc. — TRP Eye strain Relief, Sterile Eye Drops, Homeopathic, 0.33 FL OZ (10 mL)

Lack of Assurance of Sterility

Optikem International, Inc. — TRP Natural Eyes Pink Eye Relief, Sterile Eye Drops, Homeopathic, 0.33 FL OZ (10 mL)

Lack of Assurance of Sterility

Optikem International, Inc. — TRP Blur Relief, Sterile Eye Drops, Homeopathic 0.5 FL OZ (15mL)

Lack of Assurance of Sterility

Optikem International, Inc. — TRP Natural Eyes Aging Eye Relief, Sterile Eye Drops, Homeopathic, 0.33 FL OZ (10 mL)

Lack of Assurance of Sterility

Optikem International, Inc. — TRP Natural Eyes Dryness Relief, Sterile Eye Drops, 0.33 FL OZ (10 mL)

Lack of Assurance of Sterility

Optikem International, Inc. — hyalogic For Dry Eyes, HylaTears", Lubricant Eye Drops, 0.67 FL OZ (20mL) bottle

Lack of Assurance of Sterility

Optikem International, Inc. — TRP Natural Eyes Floaters Relief, Sterile Eye Drops, 0.33 FL OZ (10 mL)

Lack of Assurance of Sterility

Optikem International, Inc. — TRP Natural Eyes Allergy Eyes Relief, Sterile Eye Drops, Homeopathic 0.33 FL OZ (10mL)

Lack of Assurance of Sterility

Optikem International, Inc. — TRP Eye Twitching Relief, Sterile Eye Drops, Homeopathic 0.33 FL OZ (10 mL)

Lack of Assurance of Sterility

Seatex LLC — 7 Eleven FOR GAS ISLAND USE ONLY, Hand Sanitizer, Ethanol 70% v/v Antiseptic, Mountain Spring Scent, 330 Gal. cases

CGMP Deviations: deficiencies were identified during an FDA inspection of Seatex's manufacturing facility.

Seatex LLC — PROBLEND E3 Foaming Hand Sanitizer, All-In-One Foaming Hand Sanitizer & Cleanser, Seatex LLC, 445 TX Hwy 36 Rosenberg, TX 77471

CGMP Deviations: deficiencies were identified during an FDA inspection of Seatex's manufacturing facility.

Seatex LLC — 7 Eleven Hand Sanitizer Gel, Ethanol 70% v/v Antiseptic, Mountain Spring Scent, 1250 mL cases, Magnus 16005 Gateway Drive, Ste 300, Frisco, TX 75033

CGMP Deviations: deficiencies were identified during an FDA inspection of Seatex's manufacturing facility.

Seatex LLC — PROBLEND Hand Sanitizer, Refreshing Gel Hand Sanitizer, Ethanol 70% v/v Antiseptic, mountain spring scent, 1250 mL cases, Seatex LLC, 445 TX Hwy 36 Rosenberg, YX 77471

CGMP Deviations: deficiencies were identified during an FDA inspection of Seatex's manufacturing facility.

Seatex LLC — PROBLEND Antibacterial Foaming Silk All-In-One Foaming Hand Sanitizer & Cleanser, Benzalkonium Chloride 0.13% Antibacterial, a) 1250 mL cases, b) 1 G cases, mountain spring scent, Seatex LLC, 445 TX Hwy 36 Rosenberg, TX 77471.

CGMP Deviations: deficiencies were identified during an FDA inspection of Seatex's manufacturing facility.

Global Corporation — Broncochem Cold & Tea (acetaminophen, phenylephrine, HCl, chlorpheniramine maleate), packaged in 13g sachets, 25 sachets per box, Made in the Dominican Republic Exclusively for Global Corporation Inc, Boca Raton, FL 331

Stability testing failures for one or two of the four active pharmaceutical ingredients among the finished drug products, i.e., Phenylephrine HCL,…