May 26, 2021DrugsFDA
Nomax Inc recalls Dry Eye Test, Fluorescein Sodium, Ophthalmic Strips USP (0.12mg Fluorescein Sodium), 100 Sterile Strips (50 Pouches of 2
Hazard: Subpotent Drug
May 26, 2021DrugsFDA
KVK-Tech, Inc. recalls Hydrocodone Bitartrate and Homatropine Methlybromide tablets, USP, 5 mg/ 1.5 mg, 30-count bottle, Rx only, Mfd. By:KVK-T
Hazard: Failed Impurities/Degradation Specifications
May 26, 2021DrugsFDA
Preferred Pharmaceuticals, Inc. recalls Preferred Pharmaceuticals Inc., Metformin HCl, Extended Release Tab. USP 500 mg, Generic for Glucophage XR, Rx Only, Pkg
Hazard: CMGP Deviations: Presence of NDMA impurity detected in product and exceed the Acceptable Daily Intake Limit (ADI) of 96ng/day.
May 26, 2021DrugsFDA
Pfizer Inc. recalls Sterile Water for Inj., USP, 25 x 100 mL Single Dose Vials per carton, Rx only, For Drug Diluent Use Only, Distributed b
Hazard: Presence of Particulate Matter: particulate matter identified as an insect in one vial.
May 26, 2021DrugsFDA
Hyobin LLC recalls Triple SupremeZen Plus 3500, packaged in cardboard blisters containing one capsule per card, Distributed by Yolo Studi
Hazard: Marketed without Approved NDA/ANDA: FDA analysis results obtained the presence of tadalafil.
May 26, 2021DrugsFDA
Hyobin LLC recalls PremierZen Black 5000, packaged in cardboard blisters containing one capsule per card, Distributed by Yolo Studio, Cl
Hazard: Marketed without Approved NDA/ANDA: FDA analysis results obtained the presence of tadalafil.
May 26, 2021DrugsFDA
Hyobin LLC recalls PremierZen Extreme 3000, packaged in cardboard blisters containing one capsule per card, Distributed by Yolo Studio,
Hazard: Marketed without Approved NDA/ANDA: FDA analysis results obtained the presence of tadalafil.
May 26, 2021DrugsFDA
SigmaPharm Laboratories LLC recalls Asenapine Sublingual Tablets, 10 mg, Rx only, 60 Tablets, Sigmapharm Laboratories, LLC, Bensalem, PA, 19020, NDC 42794
Hazard: Incorrect Product Formulation; product was manufactured with the incorrect Art Cherry Flavor flavoring agent instead of Art Black Cherry Flavor flavoring agent
May 26, 2021DrugsFDA
SigmaPharm Laboratories LLC recalls Asenapine Sublingual Tablets, 5 mg, Rx Only, 60 Tablets, Sigmapharm Laboratories, LLC, Bensalem, PA, 19020 NDC 42794-
Hazard: Incorrect Product Formulation; product was manufactured with the incorrect Art Cherry Flavor flavoring agent instead of Art Black Cherry Flavor flavoring agent
May 26, 2021DrugsFDA
Teva Pharmaceuticals USA recalls Haloperidol Decanoate Injection, USP 100 mg/mL, 1 mL Single Dose Vials, Rx Only, Sterile, 10 Vials, Teva Pharmaceuticals
Hazard: Lack of Assurance of Sterility
May 26, 2021DrugsFDA
Teva Pharmaceuticals USA recalls Metoclopramide Injection USP, 10 mg/2 mL (5 mg/mL), 2 mL Single-Use Vial, Rx Only, TEVA Parenteral Medicines, Inc. Irvin
Hazard: Lack of Assurance of Sterility
May 26, 2021DrugsFDA
Teva Pharmaceuticals USA recalls Methylprednisolone Acetate Injectable Suspension USP, 40 mg/mL, 10 mL Multiple Dose Vial, Rx Only, Teva Pharmaceuticals
Hazard: Lack of Assurance of Sterility
May 26, 2021DrugsFDA
Teva Pharmaceuticals USA recalls Haloperidol Decanoate Injection, USP 50 mg/mL, 1 mL Single Dose Vials, Rx Only, Sterile, 10 Vials, Teva Pharmaceuticals,
Hazard: Lack of Assurance of Sterility
May 26, 2021DrugsFDA
Teva Pharmaceuticals USA recalls Leucovorin Calcium for Injection, equivalent to leucovorin 350 mg/vial (20 mg/mL), Rx Only, FOR IM or IV Use, Sterile, T
Hazard: Lack of Assurance of Sterility
May 19, 2021DrugsFDA
CareFusion 213, LLC recalls BD ChloraPrep Hi-Lite Orange 26 mL Applicator (2% w/v chlorhexidine gluconate (CHG) and 70% v/v Isopropyl alcohol (IPA))
Hazard: Defective Delivery System: An increase in complaints identified endcap being loose or falling off upon activation releasing glass shards containing the solution.
May 19, 2021DrugsFDA
SUN PHARMACEUTICAL INDUSTRIES INC recalls Metformin HCl Extended-Release Tablets, USP, 500 mg, packaged in 500-count bottles, Rx only, Distributed by: Sun Pharmac
Hazard: Presence of foreign substance: identified as activated carbon.
May 12, 2021DrugsFDA
QMart recalls Imperial Platinum 2000, 1 capsule, UPC 718122040702
Hazard: Marketed without Approved NDA/ANDA: FDA analysis results obtained the presence of tadalafil and/or sildenafil.
May 12, 2021DrugsFDA
QMart recalls Burro en Primavera, 2 capsules, UPC 638632431055
Hazard: Marketed without Approved NDA/ANDA: FDA analysis results obtained the presence of tadalafil and/or sildenafil.
May 12, 2021DrugsFDA
QMart recalls PremierZen Extreme 3000, Male Sexual Performance Enhancement, 1 Capsule, UPC 728175421887
Hazard: Marketed without Approved NDA/ANDA: FDA analysis results obtained the presence of tadalafil and/or sildenafil.
May 12, 2021DrugsFDA
QMart recalls IMPERIAL GOLD 2000, Male Sexual Performance Enhancement, 1 Capsule, UPC 718122040702
Hazard: Marketed without Approved NDA/ANDA: FDA analysis results obtained the presence of tadalafil and/or sildenafil.
May 12, 2021DrugsFDA
Heritage Pharmaceuticals Inc recalls Acyclovir Tablets, USP, 400 mg, 100 Tablets, Rx Only, Distributed by: Avet Pharmaceuticals Inc., East Brunswick, NJ 0881
Hazard: Labeling: Incorrect or Missing Lot and/or Exp Date
May 12, 2021DrugsFDA
Antoto-K recalls Thumbs Up 7 Red 70K, 10 count blister pack cartons, Distributed by Ummzy LLC., Made in USA, UPC 6 17135 89467 3.
Hazard: Marketed without Approved NDA/ANDA: FDA analysis results obtained the presence of sildenafil and tadalafil.
May 12, 2021DrugsFDA
PNHC, LLC. recalls heal the world, moisturizing original hand sanitizer, Non-Sterile Solution, Alcohol Antiseptic, 70% Topical Solution, 9.
Hazard: Labeling Not Elsewhere Classified: Hand sanitizer packaged in containers resembling drinking water bottles.
May 12, 2021DrugsFDA
A-S Medication Solutions LLC. recalls Acetaminophen, Extra Strength, Aspirin Free, 500 MG Tablets, 100-count bottles, Mfr: Major Pharmaceuticals, Livonia, MI
Hazard: Labeling: Label Mix-up; The bottle of over-the-counter Acetaminophen 500mg Extra Strength, 100 count, included in Health Essential Kits, labeled incorrectly with a prescription drug label instead of an OTC drug label.
May 5, 2021DrugsFDA
Genentech Inc recalls Evrysdi (risdiplam) for oral solution, 60 mg/80mL (0.75mg/mL), 80 mL total volume after constitution, Rx only, Distribut
Hazard: Defective Container: complaints received regarding some incorrect press-in-bottle-adapters (PIBA), the incorrect PIBAs have a female instead of male fit so they cannot be used in combination with co-packed syringes.
May 5, 2021DrugsFDA
Grace Healthcare Medical, Inc recalls Oxygen, Compressed, USP UN 1072, packaged in cylinders labeled as: a) M6 Medical Gas Cylinder, b) C Medical Gas Cylinder
Hazard: cGMP deviations
May 5, 2021DrugsFDA
Na Na Collection recalls Triple SupremeZen Gold 3500, Packaged in paper packaging with a pill blister,1 capsule per box, Distributed by VIEW LIFE
Hazard: Marketed without Approved NDA/ANDA: FDA analysis results obtained the presence of tadalafil and/or sildenafil.
May 5, 2021DrugsFDA
Na Na Collection recalls PremierZen Platinum 5000, Packaged in paper packaging with a pill blister, 1 capsule per box, Distributed by New Premier
Hazard: Marketed without Approved NDA/ANDA: FDA analysis results obtained the presence of tadalafil and/or sildenafil.
May 5, 2021DrugsFDA
S & B Story LLC recalls Imperial Extreme 2000 Capsules, 2000 mg, 1 count blister cards, distributed S&B Shopper LLC. Little Ferry, NJ UPC 7 1812
Hazard: Marketed without Approved NDA/ANDA: FDA analysis results obtained the presence of tadalafil and sildenafil.
May 5, 2021DrugsFDA
Namoo Enterprise LLC recalls PremierZen Black 5000 capsules, 1 capsule per card/24 capsules per box, Distributed by New Premier Group Los Angeles CA
Hazard: Marketed without Approved NDA/ANDA: FDA analysis results obtained the presence of tadalafil and sildenafil.