July 28, 2021DrugsFDA
Scentsational Soaps & Candles Inc recalls SS Lavender & Herbs Scented Sanitizer, Alcohol Antiseptic 70%, Non-sterile Topical Solution, 3.38 FL. OZ. (100 mL) a) Bl
Hazard: Chemical contamination: product found to be contaminated with methanol (wood alcohol), benzene and acetaldehyde.
July 28, 2021DrugsFDA
Scentsational Soaps & Candles Inc recalls SS Eucalyptus Mint Scented Sanitizer, Alcohol Antiseptic 70%, Non-sterile Topical Solution, 3.38 FL. OZ. (100 mL), a) Bl
Hazard: Chemical contamination: product found to be contaminated with methanol (wood alcohol), benzene and acetaldehyde.
July 28, 2021DrugsFDA
Scentsational Soaps & Candles Inc recalls SS Coconut Breeze Scented Sanitizer, Alcohol Antiseptic 70%, Non-sterile Topical Solution, 3.38 FL. OZ. (100 mL), a) Bla
Hazard: Chemical contamination: product found to be contaminated with methanol (wood alcohol), benzene and acetaldehyde.
July 28, 2021DrugsFDA
Scentsational Soaps & Candles Inc recalls Ulta beauty Fresh Lemon Citron Frais, 70% Alcohol Hand Sanitizer Spray, Net Wt. 100.55/3.4 fl. oz., UPC 717897092017
Hazard: Chemical contamination: product found to be contaminated with methanol (wood alcohol), benzene and acetaldehyde.
July 28, 2021DrugsFDA
LNK International, Inc. recalls Acetaminophen EXTRA STRENGTH Pain Reliever / Fever Reducer, Enteric Coated, 50 Coated Tablets/ 500 mg each, Distributed
Hazard: Labeling: Not Elsewhere Classified The primary label contains the words "enteric coated" but the tablet is not enteric coated and should only say 'coated tablet'
July 28, 2021DrugsFDA
Ummzy, LLC recalls Thumbs up 7 Red 70K capsules, 10-count boxes, Distributed Ummzy LLC, Made in USA, UPC 617135894680.
Hazard: Marketed Without An Approved NDA/ANDA: Products found to contain undeclared tadalafil and/ or sildenafil and vardenafil making them unapproved drugs for which the safety and efficacy have not been established and therefore subject to recall.
July 28, 2021DrugsFDA
Ummzy, LLC recalls Shogun-X capsules, 10-count boxes, Manufactured by Power Life Distributors, Made in USA, UPC 118122030185
Hazard: Marketed Without An Approved NDA/ANDA: Products found to contain undeclared tadalafil and/ or sildenafil and vardenafil making them unapproved drugs for which the safety and efficacy have not been established and therefore subject to recall.
July 28, 2021DrugsFDA
Ummzy, LLC recalls Krazy Night capsule, packaged in a) 1-count per blister card and b) 10-count boxes, Manufactured by: SUM MARKETING LLC,
Hazard: Marketed Without An Approved NDA/ANDA: Products found to contain undeclared tadalafil and/ or sildenafil and vardenafil making them unapproved drugs for which the safety and efficacy have not been established and therefore subject to recall.
July 21, 2021DrugsFDA
Prairie Wolf Spirits recalls Prairie Wolf Distillery Alcohol Antiseptic 80%, Topical Solution Hand Sanitizer, packaged in a) (16.9oz) 500 mL (UPC 8 6
Hazard: Hand sanitizer packaged in bottles that resemble beverage containers.
July 21, 2021DrugsFDA
Ardil Comercial S.R.L. recalls Limar Hand Sanitizer, Isopropyl Alcohol 70%, Cont. 4 oz bottles, Manufactured in Dominican Republic: by Ardil Comercial
Hazard: Labeling Not Elsewhere Classified: Hand sanitizer packaged in containers resembling drinking water bottles.
July 21, 2021DrugsFDA
CIPLA recalls Solifenacin Succinate Tablets, 10 mg, 30-count bottles, Rx Only, Manufactured by: Cipla Ltd., Verna, Goa, India Manufact
Hazard: CGMP Deviations
July 21, 2021DrugsFDA
Sanit Technologies, LLC dba Durisan recalls Durisan Antimicrobial Solutions (benzalkonium chloride) Hand Sanitizing Wipes, 0.13%, packaged in 80-count canister (UPC
Hazard: CGMP Deviations: lots recalled due to CGMP deviations because they were manufactured under the same conditions as product lots found to be contaminated.
July 21, 2021DrugsFDA
Sanit Technologies, LLC dba Durisan recalls Durisan Antimicrobial Solutions (benzalkonium chloride) Hand Sanitizer, listed as 0.1% or 0.13%, Alcohol-Free, packaged
Hazard: CGMP Deviations: lots recalled due to CGMP deviations because they were manufactured under the same conditions as product lots found to be contaminated.
July 21, 2021DrugsFDA
Sanit Technologies, LLC dba Durisan recalls Durisan Antimicrobial Solutions (benzalkonium chloride) Hand Sanitizing Wipes, 0.13%, 160-count canister; Sanit Technolo
Hazard: Microbial Contamination of Non-Sterile Products: firm's internal testing found certain lots of the product to be contaminated with Burkholderia contaminans and/or yeast and mold.
July 21, 2021DrugsFDA
Sanit Technologies, LLC dba Durisan recalls Durisan Antimicrobial Solutions (benzalkonium chloride) Hand Sanitizer, listed as 0.1% or 0.13%, Alcohol-Free, packaged
Hazard: Microbial Contamination of Non-Sterile Products: firm's internal testing found certain lots of the product to be contaminated with Burkholderia contaminans and/or yeast and mold.
July 21, 2021DrugsFDA
Partner Therapeutics Inc recalls LEUKINE (Sargramostim) for Injection, 250 mcg/ vial, 5mL vials, 5 (250 mcg vials) per box, Rx only, Mfd by Partner Thera
Hazard: FAILED STABILITY SPECIFICATION: Out-of-specification (OOS) result observed for Leukine (sargramostim) at the 27-month stability timepoint.
July 21, 2021DrugsFDA
Yamtun7 recalls Poseidon Platinum 3500 capsule, 1-count per blister card, Distributed by: Poseidon, Made in the USA, UPC 0 95842 05876 0
Hazard: Marketed Without An Approved NDA/ANDA: Product found to contain undeclared sildenafil and tadalafil making them unapproved drugs for which the safety and efficacy have not been established and therefore subject to recall.
July 21, 2021DrugsFDA
Grato Holdings, Inc. recalls B-Force, Homeopathic, 1 Fl Oz (30 mL) bottle, Distributed by: BioActive Nutritional, Inc., Melbourne, FL 32935, NDC 4385
Hazard: Superpotent
July 21, 2021DrugsFDA
The Harvard Drug Group recalls NIFEdipine EXTENDED-RELEASE TABLETS, USP 30 mg Rx only packaged as a) 100 count unit dose carton, NDC 0904-7080-61; b) 5
Hazard: Failed Dissolution Specification: Out of specification for dissolution during routine stability testing.
July 14, 2021DrugsFDA
Teva Pharmaceuticals USA recalls Topotecan Injection 4 mg/4mL (1 mg/mL), Single-Dose vial, Teva Pharmaceuticals USA, Inc. North Whales, PA 19454, Carton
Hazard: Presence of Particulate Matter: Complaint received of a glass particle observed inside the vial. The vial was returned to Teva for further analysis where two other particulates were found and identified as one (1) grey silicone particle and one (1) translucent, colorless cotton fiber.
July 14, 2021DrugsFDA
Fresenius Kabi USA LLC recalls Xylocaine-MPF with Epinephrine 1:200,000, (Lidocaine HCl and Epinephrine Injection, USP), 1%, 300 mg/30 mL, (10 mg/mL),
Hazard: Low out of specification results for epinephrine assay.
July 14, 2021DrugsFDA
Genentech Inc recalls Xolair (omalizumab) Injection, 150 mg/1 mL, 1 prefilled syringe, Rx Only, For Subcutaneous Use. Single-Dose Prefilled Sy
Hazard: Failed Stability Specifications: Out of Specification results of Polysorbate 20 (PS20) content were detected at the 12 month testing time point.
July 14, 2021DrugsFDA
Alvogen, Inc recalls Buprenorphine and Naloxone Sublingual Film 2mg/0.5mg, 30 pouches each containing 1 sublingual film, Distributed by: Alvo
Hazard: Subpotent drug: Out of specification for assay of naloxone and buprenorphine (low)
July 7, 2021DrugsFDA
DIBAR NUTRICIONAL S DE RL DE CV recalls ADVANCE HAND SANITIZER, (ethyl alcohol 70%), 16 FL OZ (473.2 mL), Imported by: Dibar Labs, LLC,.Sugar Land, TX 77479, Di
Hazard: CGMP Deviations: Other lots and products of hand sanitizer recalled because they were manufactured under the same conditions as the product lots found to contain methanol.
July 7, 2021DrugsFDA
DIBAR NUTRICIONAL S DE RL DE CV recalls ProtectoRx (ethyl alcohol 70%), packaged in a) 2 FL OZ (59 mL), NDC 75408-002-01 and b) 16 FL OZ (473.2 mL), NDC 75408-0
Hazard: CGMP Deviations: Other lots and products of hand sanitizer recalled because they were manufactured under the same conditions as the product lots found to contain methanol.
July 7, 2021DrugsFDA
DIBAR NUTRICIONAL S DE RL DE CV recalls DiBAR LABS Hand Sanitizer, (ethyl alcohol 70%), packaged as a) 16 FL OZ (473.1 mL) bottle, NDC 73009-001-16, UPC 8 53090
Hazard: CGMP Deviations: Other lots and products of hand sanitizer recalled because they were manufactured under the same conditions as the product lots found to contain methanol.
July 7, 2021DrugsFDA
DIBAR NUTRICIONAL S DE RL DE CV recalls DiBAR LABS Hand Sanitizer (ethyl alcohol 70%), 8 FL OZ. (236.5 mL), Distributed by S.E.N.D. LLC, Anthony, NM 88021, Impo
Hazard: Chemical Contamination: FDA analysis found 3 lots of DiBAR hand Sanitizer to be below the label claim for ethanol content and to contain methanol.
July 7, 2021DrugsFDA
HOYU(US) LOGISTICS INC recalls QiYu Hand Sanitizer (ethyl alcohol 75% (v/v)), 16.9 FL OZ (500 ML) bottles, Manufactured by: Guangzhou Minghui Cosmetics
Hazard: Subpotent
July 7, 2021DrugsFDA
NSNY Distributor Inc recalls Ginseng Power 5000 capsule, 1- count per blister card, GS Natural Co, Los Angeles, CA 90010, UPC 0 40232 18144 3
Hazard: Marketed without an approved NDA/ANDA: Products found to contain undeclared sildenafil and/ or tadalafil
July 7, 2021DrugsFDA
NSNY Distributor Inc recalls Premium OrgaZEN 7000 capsule, 1-count per blister card, distributed by: Nutra Vita Co, Santa Fe Springs, CA, Made in USA
Hazard: Marketed without an approved NDA/ANDA: Products found to contain undeclared sildenafil and/ or tadalafil