Over-the-counter & supplements recalls

A-S Medication Solutions LLC — Acetaminophen Extra Strength Tablets, 500 mg each, 100 count bottles, Packaged By: A-S Medication Solutions, Libertyville, IL 60048. NDC: 50090-5313-2

Labeling: Label Mix-Up: Some bottles of Acetaminophen Extra Strength 500 mg tablets were incorrectly labeled with the drug facts label for Aspirin 81…

Little Moon Essentials LLC — Little Moon Essentials, Clear Breeze Plus, Hand Sanitizer (Alcohol 65% v/v) Packaged as a) 2 FL OZ (60ML) spray bottle, UPC Code 6 73673 88797 3, NDC 70722-319-02; b) 4 FL OZ (118ML) spray bottle, UPC Code 6 736

CGMP deviations

Brands International Corporation — Oatmeal Daily Moisturizing Body Lotion (1.3% Dimethicone), 8 fl oz (236mL), packaged in an HDPE bottle 12 bottles per case

Microbial Contamination of Non-Sterile Products: confirmed presence of mold contamination

SYNCHRONICITY SPA INC, DBA SUNTE — suntegrity, (Zinc Oxide 15%) IMPECCABLE SKIN sunscreen foundation, Multiple Shades, Broad Spectrum SPF30, Net WT 2OZ (56.7 g), Suntegrity Skincare, Las Vegas, NV 89128, a) NDC: 69949-151-01, UPC: 854245006

CGMP Deviations

SYNCHRONICITY SPA INC, DBA SUNTE — suntegrity, (Zinc Oxide 15%) IMPECCABLE SKIN sunscreen foundation, BUFF, Broad Spectrum SPF30, Net WT 2OZ (56.7 g), Suntegrity Skincare, Las Vegas, NV 89128, NDC: 69949-152-01 UPC 854245006187

Microbial Contamination of Non-Sterile Products: Presence of Aspergillus Sydowii (Mold)

MexHealth LLC — OSSOS-SANS Reforzado con: Glucosamina Curcuma Ortiga tablets, packaged in a 30-count bottle, DISTRIBUIDOR POR: Naturistas Especializados, Alce Blanco 180-A Fracc. Industrial, Edo. de Mexico C.P. 53370

Marketed Without An Approved NDA/ANDA: FDA laboratory analysis found the product to contain undeclared diclofenac and methocarbamol,

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.

Contract Pharmacal Corporation — Extra Strength Acetaminophen 500 MG Tablets,100-count Bottle

Discoloration: Brownish tablets

Pharma Nobis LLC — Meijer Magnesium Citrate Saline Laxative Oral Solution Dye Free, Sugar Free Grape, 10 fl. oz bottle

Microbial Contamination of Non-Sterile Products - Presence of Acetobacter nitrogenifigens bacteria

Pharma Nobis LLC — CVS Health Magnesium Citrate Saline Laxative Oral Solution DYE FREE Cherry Flavor, 10 fl. oz bottle

Microbial Contamination of Non-Sterile Products - Presence of Acetobacter nitrogenifigens bacteria

Stop Clopez Corp — Schwinnng Herbal Dietary Supplement Capsules, packaged in 10-count boxes

Marketed Without An Approved NDA/ANDA

ARG Laboratories, Inc. — Bull Frog SPF 50 Amphibious Lotion SPF 50 Amphibious Lotion with Water Armor Tech, Broad Spectrum Sunscreen with UVA/UVB Protection, NEW WT. 5 FL OZ (148ML)

Out of Specification for active ingredient

Aruba Aloe Balm N.V. — Aruba Aloe Hand Sanitizer Gel, 80% Alcohol, 12 fl oz (355 mL) plastic bottle

Chemical Contamination: Product manufactured with ethanol API that contains methanol

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.

Aruba Aloe Balm N.V. — Alcoholada Gel, Pain Relieving Gel, 0.5% Lidocaine Hydrochloride, packaged in (a) 8.5 fl oz (251 mL) plastic bottle UPC 0 82252 03120 9 (b) 2.2 fl oz (65 mL) plastic bottle, UPC 0 82252 34030 1

Chemical Contamination: Product manufactured with ethanol API that contains methanol

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. — Spanish Fly 22K capsules, 2-count box, UPC 0 664979 979455

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. — GoHARD 25000, Male Sexual Enhancement, Honey, 100% Natural, UPC: N/A.

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. — Samurai-X Honey 6800, UPC 2 56891 27553 3.

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. — libigrow RED DRAGON+, Maximum Strength Formula, 2 capsules per box, UPC 7 05105 83073 5.

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. — SILVERBACK XXX POWER MALE ENHANCEMENT, 2 fl. oz., UPC 8 700470 032762

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. — Flower Power, CBD infused Female Enhancement, 59 ml bottle, UPC 0 678741 351646.

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. — HONEY MANUKA BUNNY LOVE, 12g, All Natural Sexual Enhancement, UPC: N/A

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.