September 23, 2020DrugsFDA
RLC Labs Inc. recalls WP Thyroid, Westhroid Pure, Thyroid USP, [liothyronine (T3) 2.25 mcg and levothyroxine (T4) 9.5 mcg], 1/4 Grain (16.25 m
Hazard: CGMP Deviations: manufactured under the same conditions as those found to be subpotent.
September 23, 2020DrugsFDA
RLC Labs Inc. recalls Nature-Throid, Thyroid USP [liothyronine (T3) 27 mcg and levothyroxine (T4) 114 mcg], 3 Grain (195 mg) Tablets, packaged
Hazard: CGMP Deviations: manufactured under the same conditions as those found to be subpotent.
September 23, 2020DrugsFDA
RLC Labs Inc. recalls Nature-Throid, Thyroid USP [liothyronine (T3) 22.5 mcg and levothyroxine (T4) 95 mcg], 2.5 Grain (162.5 mg) Tablets, pac
Hazard: CGMP Deviations: manufactured under the same conditions as those found to be subpotent.
September 23, 2020DrugsFDA
RLC Labs Inc. recalls Nature-Throid, Thyroid USP [liothyronine (T3) 20.25 mcg and levothyroxine (T4) 85.5 mcg], 2.25 Grain (146.25 mg) Tablets
Hazard: CGMP Deviations: manufactured under the same conditions as those found to be subpotent.
September 23, 2020DrugsFDA
RLC Labs Inc. recalls Nature-Throid, Thyroid USP [liothyronine (T3) 18 mcg and levothyroxine (T4) 76 mcg], 2 Grain (130 mg) Tablets, packaged
Hazard: CGMP Deviations: manufactured under the same conditions as those found to be subpotent.
September 23, 2020DrugsFDA
RLC Labs Inc. recalls Nature-Throid, Thyroid USP [liothyronine (T3) 15.75 mcg and levothyroxine (T4) 66.5 mcg], 1.75 Grain (113.75 mg) Tablets
Hazard: CGMP Deviations: manufactured under the same conditions as those found to be subpotent.
September 23, 2020DrugsFDA
RLC Labs Inc. recalls Nature-Throid, Thyroid USP [liothyronine (T3) 13.5 mcg and levothyroxine (T4) 57 mcg], 1.5 Grain (97.5 mg) Tablets, pack
Hazard: CGMP Deviations: manufactured under the same conditions as those found to be subpotent.
September 23, 2020DrugsFDA
RLC Labs Inc. recalls Nature-Throid, Thyroid USP [liothyronine (T3) 11.25 mcg and levothyroxine (T4) 47.5 mcg], 1.25 Grain (81.25 mg) Tablets
Hazard: CGMP Deviations: manufactured under the same conditions as those found to be subpotent.
September 23, 2020DrugsFDA
RLC Labs Inc. recalls Nature-Throid, Thyroid USP [liothyronine (T3) 4.5 mcg and levothyroxine (T4) 19 mcg], 1/2 Grain (32.5 mg) Tablets, packa
Hazard: CGMP Deviations: manufactured under the same conditions as those found to be subpotent.
September 23, 2020DrugsFDA
RLC Labs Inc. recalls Nature-Throid, Thyroid USP [liothyronine (T3) 6.75 mcg and levothyroxine (T4) 28.5 mcg], 3/4 Grain (48.75 mg) Tablets, p
Hazard: CGMP Deviations: manufactured under the same conditions as those found to be subpotent.
September 23, 2020DrugsFDA
RLC Labs Inc. recalls Nature-Throid, Thyroid USP [liothyronine (T3) 9 mcg and levothyroxine (T4) 38 mcg], 1 Grain (65 mg) Tablets, packaged in
Hazard: CGMP Deviations: manufactured under the same conditions as those found to be subpotent.
September 23, 2020DrugsFDA
Exela Pharma Sciences LLC recalls Potassium Acetate Injection, USP 40 mEq/20 mL (2 mEq/mL) Single Dose Vials, Rx only, Manufactured By: Exela Pharma Scie
Hazard: Short Fill
September 23, 2020DrugsFDA
Maison Terre, LLC recalls Goldenseal Root Powder Organic, 1 oz. clear plastic bag, Maison Terre Natural Products, www.maisonterre.net
Hazard: Microbial Contamination of Non-Sterile Products: FDA laboratory analysis found product to be contaminated with various microorganisms including Enterobacter cloacae, Cronobacter sakazakii, Cronobacter dublinensis, among others.
September 23, 2020DrugsFDA
Real Clean Distribuciones SA de CV recalls BORN BASIC., ANTI-BAC HAND SANITIZER, 70% Alcohol, (Ethyl Alcohol 70%), 16.9 FL OZ (500 mL) bottle, UPC 8 40038 21456 3,
Hazard: Chemical Contamination: Born Basic Anti Bac was found to be below the label claim for ethanol content and contained methanol. Other products were recalled because they were manufactured in the same facility as the product found to contain methanol.
September 23, 2020DrugsFDA
Real Clean Distribuciones SA de CV recalls LUX EOI Hand Sanitizing Gel, (Ethyl Alcohol 70%), (16.9 FL OZ) 500mL bottle, Distributed by: Procurement Services, LLC N
Hazard: CGMP Deviations: Born Basic Anti Bac was found to be below the label claim for ethanol content and contained methanol. Other products were recalled because they were manufactured in the same facility as the product found to contain methanol.
September 23, 2020DrugsFDA
Real Clean Distribuciones SA de CV recalls BORN BASIC., ANTI-BAC HAND SANITIZER, 70% Alcohol, (Ethyl Alcohol 70%), packaged as a) 9.5 FL OZ (280 mL) bottle, UPC 8
Hazard: CGMP Deviations: Born Basic Anti Bac was found to be below the label claim for ethanol content and contained methanol. Other products were recalled because they were manufactured in the same facility as the product found to contain methanol.
September 23, 2020DrugsFDA
Real Clean Distribuciones SA de CV recalls scent theory KEEP CLEAN Moisturizing Hand Sanitizer, 70% alcohol (Ethyl Alcohol 70%), 16.9 FL OZ/500 mL bottle, Distribu
Hazard: CGMP Deviations: Born Basic Anti Bac was found to be below the label claim for ethanol content and contained methanol. Other products were recalled because they were manufactured in the same facility as the product found to contain methanol.
September 23, 2020DrugsFDA
Real Clean Distribuciones SA de CV recalls scent theory KEEP IT CLEAN, pure clean,(Ethyl Alcohol 70%), 16.9 FL OZ/500 mL, Distributed by Scent Theory Products, LLC
Hazard: CGMP Deviations: Other products were recalled because they were manufactured in the same facility as the product found to contain methanol.
September 23, 2020DrugsFDA
Broncolin, S.A. de C.V. recalls HERBACIL, Antiseptic Hand Sanitizer, 70% Alcohol, (Alcohol) 70%, packaged as a) 4.22 fl. oz. (125ml) bottle, UPC 7 14706
Hazard: Chemical Contamination: HERBACIL, Antiseptic Hand Sanitizer, 70% Alcohol, was found to be below the label claim for ethanol content and contained methanol.
September 23, 2020DrugsFDA
Broncolin, S.A. de C.V. recalls HERBACIL, Antiseptic Hand Sanitizer, 70% Alcohol, (Alcohol) 70%, packaged as a) 4.22 fl. oz. (125ml) bottle, UPC 7 14706
Hazard: CGMP Deviations: products were recalled because they were manufactured in the same facility as the product found to contain methanol.
September 16, 2020DrugsFDA
Teva Pharmaceuticals USA recalls Cephalexin for Oral Suspension, USP 250 mg per 5 mL, For Reconstitution, For Oral Use Only, Rx Only, 100 mL bottle when
Hazard: Sub-Potent Drug: Out of specification test results for potency (below specification).
September 16, 2020DrugsFDA
Maquiladora Miniara Sa De Cv recalls Shine & Clean Hand Sanitizer gel, (Ethyl Alcohol 70%), 33.81 fl oz (1L) bottle, Made in Mexico By: Maquiladora Miniara S
Hazard: CGMP Deviations: Products manufactured at the same site were FDA testing found below the label claim for ethanol content and the presence of undeclared methanol.
September 16, 2020DrugsFDA
Open Book Extracts recalls Just Hand Sanitizer (Ethyl Alcohol 73%) Single Use-Packs 100-count NDC 78065-2020-2 UPC 703123998598 (Single packs NDC 7
Hazard: Labeling Not Elsewhere Classified: Product labeled to contain methanol
September 16, 2020DrugsFDA
Open Book Extracts recalls Always Be Clean Hand Sanitizer (73% Alcohol) 0.04 FL OZ (1.2 mL) packaged in a) Single snaps (NDC 75091-2020-1 UPC 37509
Hazard: Labeling Not Elsewhere Classified: Product labeled to contain methanol
September 16, 2020DrugsFDA
Edge Pharma, LLC recalls Vancomycin HCL 1.5 mg Edge Pharma, LLC 856 Hercules Dr. Colchester, VT 05446 NDC 05446-1458-01
Hazard: Labeling: Label Error on Declared Strength
September 16, 2020DrugsFDA
Teva Pharmaceuticals USA recalls Cephalexin for Oral Suspension, USP 250 mg per 5 mL, For Reconstitution, For Oral Use Only, Rx Only, a) 100 mL bottle wh
Hazard: CGMP deviations; there is a possibility that some bottles in these lots may have the active ingredient above and/or below specification limits.
September 16, 2020DrugsFDA
Teva Pharmaceuticals USA recalls Cephalexin for Oral Suspension, USP 125 mg per 5 mL, For Reconstitution, For Oral Use Only, Rx Only, a) 100 mL bottle wh
Hazard: CGMP deviations; there is a possibility that some bottles in these lots may have the active ingredient above and/or below specification limits.
September 9, 2020DrugsFDA
Mylan Institutional LLC recalls Tranexamic Acid Injection, USP, 1000 mg/10 mL (100 mg/mL), 10 mL Single-Dose Vial (NDC 67457-197-00); 10 x 10 mL Single-
Hazard: Labeling: Label Mix-Up; potential for cartons labeled as Tranexamic Acid Injection, USP to contain vials of Amiodarone HCl Injection, USP and cartons labeled as Amiodarone HCl Injection, USP to contain vials of Tranexamic Acid Injection, USP.
September 9, 2020DrugsFDA
Mylan Institutional LLC recalls Amiodarone Hydrochloride Injection, USP, 450 mg/9 mL (50 mg/mL), 9 mL Single-Dose Vial (NDC 67457-153-99); 10 x 9 mL Sin
Hazard: Labeling: Label Mix-Up; potential for cartons labeled as Tranexamic Acid Injection, USP to contain vials of Amiodarone HCl Injection, USP and cartons labeled as Amiodarone HCl Injection, USP to contain vials of Tranexamic Acid Injection, USP.
September 9, 2020DrugsFDA
SG24 LLC recalls Skin Guard 24 All-Day Hand Sanitizer 1 4"x6" Hand Sanitizing Towelette packaged in 2.5 x 3.75 packets, Dist by: SG24 LLC
Hazard: Marketed without an Approved NDA/ANDA; product labeled to contain 0.56% methanol making it an unapproved new drug