January 22, 2020DrugsFDA
Motto International Corp recalls Bull Platinum 30000 Capsules, 1000 mg, in orange, white, yellow background with silver text, packaged in 2, 4 and 10 cou
Hazard: Marketed without an Approved NDA/ANDA; FDA analysis found product to contain tadalfil
January 15, 2020DrugsFDA
Idelle Labs recalls SURE 48hr Confidence Unscented Original Solid Anti-Perspirant & Deodorant Net Wt 2.7 oz (76g) NDC# 41595-5513-2 UPC 8 83
Hazard: Labeling Product Contains Undeclared API: Active Ingredient on label is not the active ingredient in the product.
January 15, 2020DrugsFDA
Idelle Labs recalls SURE 48hr Confidence Regular Original Solid Anti-Perspirant & Deodorant Net Wt 2.7 oz (76g) NDC# 41595-5514-1 UPC 8 8348
Hazard: Labeling Product Contains Undeclared API: Active Ingredient on label is not the active ingredient in the product.
January 15, 2020DrugsFDA
Idelle Labs recalls SURE 48hr Confidence Nourishing Coconut invisible solid Antiperspirant & Deodorant Net Wt 2.6 oz (73g) NDC# 41595-5547-1
Hazard: Labeling Product Contains Undeclared API: Active Ingredient on label is not the active ingredient in the product.
January 15, 2020DrugsFDA
Idelle Labs recalls SURE 48 hr Confidence Unscented invisible solid Anti-Perspirant & Deodorant, Net Wt. 2.6 oz (73g) NDC# 41595-5509-2 UPC
Hazard: Labeling Product Contains Undeclared API: Active Ingredient on label is not the active ingredient in the product.
January 15, 2020DrugsFDA
Asclemed USA Inc. dba Enovachem Pharmaceuticals recalls Estriol, USP, (Micronized), 0.24 g, Distributed by Enovachem Pharmaceuticals, Torrance CA; NCD #76420-049-38
Hazard: Failed Impurities/Degradation Specifications: Additional testing found Out of Specification impurity test results.
January 15, 2020DrugsFDA
Asclemed USA Inc. dba Enovachem Pharmaceuticals recalls Estriol, USP, (Micronized), 0.12 g, Distributed by Enovachem Pharmaceuticals, Torrance CA; NCD #76420-049-37
Hazard: Failed Impurities/Degradation Specifications: Additional testing found Out of Specification impurity test results.
January 15, 2020DrugsFDA
Asclemed USA Inc. dba Enovachem Pharmaceuticals recalls Estriol, USP, (Micronized), 0.06 g, Distributed by Enovachem Pharmaceuticals, Torrance CA; NCD #76420-049-36
Hazard: Failed Impurities/Degradation Specifications: Additional testing found Out of Specification impurity test results.
January 15, 2020DrugsFDA
Appco Pharma LLC recalls Ranitidine Capsules 150 mg, (a) 60 count bottles (NDC 62559-690-60) , (b) 500 count bottles (NDC 62559-690-05), Rx only,
Hazard: CGMP Deviations: Impurity N-nitrosodimethylamine (NDMA) found in API
January 15, 2020DrugsFDA
Appco Pharma LLC recalls Ranitidine Capsules 300 mg, 30 count bottles. Rx only, Manufactured by: Appco Pharma LLC, Piscataway, NJ 08854, Distribu
Hazard: CGMP Deviations: Impurity N-nitrosodimethylamine (NDMA) found in API
January 15, 2020DrugsFDA
AAA Pharmaceutical, Inc. recalls Ranitidine 150 mg tablets, 130 count bottles, NDC 37808-196-04.
Hazard: CGMP Deviations: Impurity N-nitrosodimethylamine (NDMA) found in API
January 15, 2020DrugsFDA
AAA Pharmaceutical, Inc. recalls Ranitidine 150 mg tablets, 24 count bottles, NDC 37808-196-01.
Hazard: CGMP Deviations: Impurity N-nitrosodimethylamine (NDMA) found in API
January 15, 2020DrugsFDA
Glenmark Pharmaceuticals Inc., USA recalls Glenmark Ranitidine Tablets USP 150 mg Rx Only 500 Tablets Manufactured by: Glenmark Pharmaceuticals Ltd. Colvale-Bandez
Hazard: CGMP Deviations: Presence of NDMA impurity detected in product.
January 15, 2020DrugsFDA
Glenmark Pharmaceuticals Inc., USA recalls Glenmark Ranitidine Tablets USP 300 mg Rx Only 250 Tablets Manufactured by: Glenmark Pharmaceuticals Ltd. Colvale-Bandez
Hazard: CGMP Deviations: Presence of NDMA impurity detected in product.
January 15, 2020DrugsFDA
Glenmark Pharmaceuticals Inc., USA recalls Glenmark Ranitidine Tablets USP 300 mg Rx Only 100 Tablets Manufactured by: Glenmark Pharmaceuticals Ltd. Colvale-Bandez
Hazard: CGMP Deviations: Presence of NDMA impurity detected in product.
January 15, 2020DrugsFDA
Glenmark Pharmaceuticals Inc., USA recalls Glenmark Ranitidine Tablets USP 300 mg Rx Only 30 Tablets Manufactured by: Glenmark Pharmaceuticals Ltd. Colvale-Bandez,
Hazard: CGMP Deviations: Presence of NDMA impurity detected in product.
January 15, 2020DrugsFDA
Glenmark Pharmaceuticals Inc., USA recalls Glenmark Ranitidine Tablets USP 150 mg Rx Only 100 Tablets Manufactured by: Glenmark Pharmaceuticals Ltd. Colvale-Bandez
Hazard: CGMP Deviations: Presence of NDMA impurity detected in product.
January 15, 2020DrugsFDA
Glenmark Pharmaceuticals Inc., USA recalls Glenmark Ranitidine Tablets USP 150 mg Rx Only 60 Tablets Manufactured by: Glenmark Pharmaceuticals Ltd. Colvale-Bandez,
Hazard: CGMP Deviations: Presence of NDMA impurity detected in product.
January 15, 2020DrugsFDA
Lupin Pharmaceuticals Inc. recalls Blisovi Fe 1.5/30 (norethindrone acetate and ethinyl estradiol tablets USP and ferrous fumarate tablets 75mg), Rx Only,
Hazard: Failed Tablet/Capsule Specifications: Complaints related to crumbling of tablets when popped out of the blister pack.
January 8, 2020DrugsFDA
Akorn, Inc. recalls MYORISAN (isotretinoin capsules, USP), 20mg, packaged in 30-count Capsules (3 x 10 Prescription Packs) per box, Rx only,
Hazard: Unit Dose Mispackaging: Customer complaint that a carton labeled as Myorisan 20 mg Capsules, USP erroneously contained one 10-count blister card of the 40 mg product in addition to two 10-count blister cards of the 20 mg product.
January 8, 2020DrugsFDA
Lupin Pharmaceuticals Inc. recalls Bimatoprost Ophthalmic Solution, 0.03%, For Use in the Eyes Only, Sterile, Rx Only, 7.5 mL bottle, Manufactured by: Lupi
Hazard: Failed Impurities/Degradation Specifications: Out-of-specification result observed in any other individual impurity.
January 8, 2020DrugsFDA
Island Kinetics, Inc. d.b.a. CoValence Laboratories recalls PCA Skin Blemish Control Bar, 3.2 oz/90g, Salicylic acid 2% - Acne cleanser, For external use only, Distributed by PCA S
Hazard: Superpotent Drug: Salicylic acid content is above the firm's specification.
January 8, 2020DrugsFDA
Natures Rx recalls Silver Bullet, Get Bigger and Harder, Works in Minutes, Lasts for Days, 10 male enhancement capsules in blister foil pac
Hazard: Marketed Without an Approved NDA/ANDA; Product contains undeclared active ingredient - Sildenafil.
January 8, 2020DrugsFDA
Granules India Limited recalls RANITIDINE TABLETS, USP 150mg, 10,000-count bag, Country of Origin: INDIA NDC 62207-773-32
Hazard: CGMP Deviations: Impurity N-nitrosodimethylamine (NDMA) found in API
January 8, 2020DrugsFDA
American Health Packaging recalls Ranitidine Syrup (Ranitidine Oral Solution USP), 15 mg/mL, 150 mg/10 mL per cup, Rx Only, Distributed by: American Healt
Hazard: CGMP Deviations: Presence of NDMA impurity detected in product.
January 1, 2020DrugsFDA
Spectrum Laboratory Products recalls Estriol [(16a, 17B)-Estra-1,3,5(10)-triene-3,16,17-triol; Oestriol] Micronized, USP, CAS 50-27-1, packaged in a) 1 G gla
Hazard: Subpotent Drug: Supplier indicated assay results did not meet specifications.
January 1, 2020DrugsFDA
Pharmedium Services, LLC recalls NORepinephrine Bitartrate 4 mg added to 250 mL 5% Dextrose Injection USP (16 mcg per mL) Total Volume 254.00 mL Viaflex
Hazard: Subpotent Drug
January 1, 2020DrugsFDA
Pharmedium Services, LLC recalls NORepinephrine Bitartrate 8 mg added to 500 mL 5% Dextrose Injection USP (16 mcg per mL) Total Volume 508.00 mL Viaflex
Hazard: Subpotent Drug
January 1, 2020DrugsFDA
Pharmedium Services, LLC recalls NORepinephrine Bitartrate 8 mg added to 250 mL 5% Dextrose Injection USP (32 mcg per mL) Total Volume 258.00 mL Viaflex
Hazard: Subpotent Drug
December 25, 2019DrugsFDA
AuroMedics Pharma LLC recalls Gabapentin Capsules, USP 100 mg, Rx Only, Distributed by: Aurobindo Pharma USA, Inc. Dayton, NJ 08810, NDC 65682-198-99
Hazard: Presence of Foreign Tablets/Capsules: One Losartan/HCTZ tablet was found in Gabapentin 1000 count bottles..