October 7, 2020DrugsFDA
P & L Developments, LLC recalls Nicotine Gum, Nicotine Polacrilex Gum USP, 2 mg (nicotine), 110-count pieces per carton, Distributed By: Rite Aid, 30 Hu
Hazard: Labeling: Incorrect or Missing Package Insert: The package insert included in the finished product is for the Canadian market and is not part of the current approved drug labeling.
October 7, 2020DrugsFDA
Teva Pharmaceuticals USA recalls Buprenorphine Transdermal System 5 mcg/hour, 4 transdermal systems/4 disposal units per carton, Rx Only, Manufactured by
Hazard: Failed Stability Specifications: Below specification result for buprenorphine release rate.
October 7, 2020DrugsFDA
SUN PHARMACEUTICAL INDUSTRIES INC recalls RIOMET ER (metformin hydrochloride for extended-release oral suspension), 500 mg per 5 mL 16 oz. For Oral Use Only Rx On
Hazard: CGMP Deviations: Detection of N-nitrosodimethylamine (NDMA) impurity in finished drug product.
October 7, 2020DrugsFDA
Strides Inc. recalls Strides Pharma Inc.Potassium Chloride Extended-Release Tablets, USP 8mEq (600 mg) 100 Tablets Rx Only Manufactured by:
Hazard: Failed Dissolution Specifications
September 30, 2020DrugsFDA
Preferred Pharmaceuticals, Inc. recalls Nature-Throid, 1.5 Grain, (97.5 mg), (Thyroid U.S.P. 1.5 gr. (97.5mg)/Liothyronine (T3) 13.5mcg/Levothyroxine (T4) 57mcg
Hazard: CGMP Deviations
September 30, 2020DrugsFDA
Preferred Pharmaceuticals, Inc. recalls Nature-Throid, 1 Grain, 65 mg (Thyroid U.S.P. 1 gr. (65mg)/Liothyronine (T3) 9mcg/Levothyroxine (T4) 38mcg, packaged in
Hazard: CGMP Deviations
September 30, 2020DrugsFDA
Preferred Pharmaceuticals, Inc. recalls Nature-Throid, 3/4 Grain (48.75 mg) Thyroid U.S.P. 3/4 gr. (48.75 mg)/Liothyronine (T3) 6.75mcg/Levothyroxine (T4) 28.5m
Hazard: CGMP Deviations
September 30, 2020DrugsFDA
Preferred Pharmaceuticals, Inc. recalls Nature-Throid, 1/2 Grain, 32.5 mg (Thyroid U.S.P. 1/2 gr. (32.5 mg)/Liothyronine (T3) 4.5mcg/Levothyroxine (T4) 19mch, 1
Hazard: CGMP Deviations
September 30, 2020DrugsFDA
AJR TRADING LLC recalls bio aaa Alcohol en Gel Antibacterial, Alcohol al 70% Cont. Neto 480 ml bottle, Hecho en Mexico por: AAA Cosmetica S.A. D
Hazard: CGMP Deviations: Product manufactured in a facility where methanol was found in other distributed lots of product.
September 30, 2020DrugsFDA
The Protein Shoppe recalls Red-E Tablet, Proprietary Blend 3000 mg**, packaged in 1-count plastic bag stapled with cardboard labeling.
Hazard: Marketed Without An Approved NDA/ANDA: product found to be tainted with sildenafil, an FDA approved drug for the treatment of male erectile dysfunction, making this an unapproved drug fro which the safety and efficacy have not been established and therefore subject to recall.
September 30, 2020DrugsFDA
Perrigo Company PLC recalls Albuterol Sulfate Inhalation Aerosol, 90 mcg per actuation, 200 metered inhalations, Manufactured by: Catalent Pharma So
Hazard: Defective Delivery System: Sustained trend of failure to dispense complaints.
September 30, 2020DrugsFDA
Nanomateriales Sa De Cv recalls Zanilast+ Gel Antiseptic Hand Sanitizer (70% Ethyl Alcohol) Packaged in 25 kg bottles, Distributed by Fujimura Trading
Hazard: GMP Deviations: Potential to contain 1-propanol.
September 30, 2020DrugsFDA
Nanomateriales Sa De Cv recalls Zanilast+ Gel Antiseptic Hand Sanitizer (70% Ethyl Alcohol) Packaged in a) 33.8 fl oz (1.06 qt) (1L) (NDC 69912-008-01 U
Hazard: GMP Deviations: Potential to contain 1-propanol.
September 30, 2020DrugsFDA
GRUPO YACANA MEXICO SAS DE CV recalls Yacana Alcohol Antiseptic 70% Topical Solution 8.5 oz (250 mL), OTC, Manufactured by: Greensys of North America LLC. 500
Hazard: cGMP Deviations
September 30, 2020DrugsFDA
GRUPO YACANA MEXICO SAS DE CV recalls Yacana Alcohol Antiseptic 70% Topical Solution 8.5 oz (250 mL), OTC, Manufactured by: Grupo Yacana Mexico SAS de CV Ave.
Hazard: cGMP Deviations
September 30, 2020DrugsFDA
Incredible Products, SA de CV recalls Incredible Products Gelbac T Antibacterial Hand Gel (ethyl alcohol 80%), Kills 99.9% bacteria and germs, a) 4.2 Oz./125
Hazard: Chemical Contamination: Product contains methanol as an active ingredient and is sub-potent for ethanol.
September 30, 2020DrugsFDA
CORGIOMED LLC recalls Leafree Instant Hand Sanitizer Aloe Vera (ethyl alcohol 70% v/v), Kills 99.99% Germs, EDIBLE ALCOHOL, a) 100 mL bottles,
Hazard: Marketed without an Approved NDA/ANDA; product labeled as Edible Alcohol rendering the product an unapproved new drug and misbranded.
September 23, 2020DrugsFDA
RLC Labs Inc. recalls Nature Throid, 1.5 Grain (97.5 mg) Thyroid USP [Liothyronine (T3) 13.5 mcg, Levothyroxine (T4) 57 mcg], packaged in a) 3
Hazard: Subpotent Drug: FDA analysis found product to be subpotent
September 23, 2020DrugsFDA
RLC Labs Inc. recalls Nature Throid, 2 Grain (130 mg) Thyroid USP [Liothyronine (T3) 18 mcg, Levothyroxine (T4) 76 mcg], packaged in a) 30-cou
Hazard: Subpotent Drug: FDA analysis found product to be subpotent
September 23, 2020DrugsFDA
RLC Labs Inc. recalls Nature Throid, 1.25 Grain (81.25 mg) Thyroid USP [Liothyronine (T3) 11.25 mcg, Levothyroxine (T4) 47.5 mcg], 100-count b
Hazard: Subpotent Drug: FDA analysis found product to be subpotent
September 23, 2020DrugsFDA
RLC Labs Inc. recalls Nature Throid, 3/4 Grain (48.75 mg) Thyroid USP [Liothyronine (T3) 6.75 mcg, Levothyroxine (T4) 28.5 mcg], packaged in a
Hazard: Subpotent Drug: FDA analysis found product to be subpotent
September 23, 2020DrugsFDA
RLC Labs Inc. recalls Nature Throid, 1/2 Grain (32.5 mg) Thyroid USP [Liothyronine (T3) 4.5 mcg, Levothyroxine (T4) 19 mcg], packaged in a) 90
Hazard: Subpotent Drug: FDA analysis found product to be subpotent
September 23, 2020DrugsFDA
RLC Labs Inc. recalls WP Thyroid, Westhroid Pure, 1/2 Grain (32.5 mg) Thyroid USP [Liothyronine (T3) 4.5 mcg, Levothyroxine (T4) 19 mcg], pack
Hazard: Subpotent Drug: FDA analysis found product to be subpotent
September 23, 2020DrugsFDA
RLC Labs Inc. recalls WP Thyroid, Westhroid Pure, 2 Grain (130 mg) Thyroid USP packaged in a) 1,000 Tablets, NDC 64727-5950-2 ; b) 30 Tablets,
Hazard: CGMP Deviations: manufactured under the same conditions as those found to be subpotent.
September 23, 2020DrugsFDA
RLC Labs Inc. recalls WP Thyroid, Westhroid Pure, 1.75 Grain (113.75 mg) Thyroid USP, packaged in a) 1,000 Tablets, NDC 64727-6150-2 ; b) 30 T
Hazard: CGMP Deviations: manufactured under the same conditions as those found to be subpotent.
September 23, 2020DrugsFDA
RLC Labs Inc. recalls WP Thyroid, Westhroid Pure, 1.5 Grain (97.5 mg) Thyroid USP packaged in a) 1,000 Tablets, NDC 64727-5850-2 ; b) 30 Table
Hazard: CGMP Deviations: manufactured under the same conditions as those found to be subpotent.
September 23, 2020DrugsFDA
RLC Labs Inc. recalls WP Thyroid, Westhroid Pure, 1.25 Grain (81.25 mg) Thyroid USP packaged in a) 1,000 Tablets, NDC 64727-6050-2 ; b) 30 Tab
Hazard: CGMP Deviations: manufactured under the same conditions as those found to be subpotent.
September 23, 2020DrugsFDA
RLC Labs Inc. recalls WP Thyroid, Westhroid Pure, 1 Grain (65 mg) Thyroid USP, packaged in a) 1,000 Tablets, NDC 64727-5750-2 ; b) 30 Tablets,
Hazard: CGMP Deviations: manufactured under the same conditions as those found to be subpotent.
September 23, 2020DrugsFDA
RLC Labs Inc. recalls WP Thyroid, Westhroid Pure, 3/4 Grain (48.75 mg) Thyroid USP, packaged in a) 1,000 Tablets, NDC 64727-5650-2 ; b) 30 Tab
Hazard: CGMP Deviations: manufactured under the same conditions as those found to be subpotent.
September 23, 2020DrugsFDA
RLC Labs Inc. recalls WP Thyroid, Westhroid Pure, 1/2 Grain (32.5 mg) Thyroid USP packaged in a) 1,000 Tablets, NDC 64727-5550-2 ; b) 30 Table
Hazard: CGMP Deviations: manufactured under the same conditions as those found to be subpotent.