June 24, 2020DrugsFDA
Glaxosmithkline Consumer Healthcare Holdings recalls Gaviscon Regular Strength Liquid Antacid Cool Mint, 12 FL OZ (355 mL), Distributed by: GSK Consumer Healthcare Warren, N
Hazard: Labeling: Label lacks warning - Magnesium safety warning is not present on the Gaviscon bottle label.
June 24, 2020DrugsFDA
Glaxosmithkline Consumer Healthcare Holdings recalls Gaviscon Regular Strength Liquid Antacid Cool Mint, 6 FL OZ (177 mL), Distributed by: GSK Consumer Healthcare Warren, NJ
Hazard: Labeling: Label lacks warning - Magnesium safety warning is not present on the Gaviscon bottle label.
June 24, 2020DrugsFDA
Aurobindo Pharma USA Inc. recalls Olanzapine Tablets, USP 7.5 mg, 30-count bottle, Rx only, Manufactured for: Prasco Laboratories Mason, OH 45040 USA, Man
Hazard: Failed Impurities/ Degradation Specifications
June 24, 2020DrugsFDA
Aurobindo Pharma USA Inc. recalls Olanzapine Tablets, USP 2.5 mg, 30-count bottle, Rx only, Manufactured for: Prasco Laboratories Mason, OH 45040 USA, Man
Hazard: Failed Impurities/ Degradation Specifications
June 24, 2020DrugsFDA
SCA Pharmaceuticals recalls Heparin Sodium 5,000 units in 0.9% Sodium Chloride 1000 mL bag (5 units/mL), Rx Only, SCA Pharmaceuticals 755 Rainbow Rd
Hazard: Subpotent Drug: Out-of-Specification potency results at the 30-day stability timepoint.
June 24, 2020DrugsFDA
Eco Lips Inc recalls EcoLips Sport Lip Balm, SPF 30, Avobenzone (5%), Octinoxate (10%), Octisalate (5%), Net Wt. 0.15 oz. (4.25g) tube, Eco L
Hazard: Superpotent Drug: The active ingredient, avobenzone, is used at 5% which is higher than the allowable 3% in the sunscreen formula per FDA sunscreen regulations.
June 24, 2020DrugsFDA
Hikma Pharmaceuticals USA Inc. recalls Irinotecan HCL Injection, USP, 100mg/5mL, 5 mL vials, Rx only, Manufactured by: Thymoorgan Pharmazie GmbH, Shiffgraben 2
Hazard: Defective Container: Customer complaints received of a crimp defect while removing the flip-cap during use.
June 24, 2020DrugsFDA
Hikma Pharmaceuticals USA Inc. recalls Irinotecan HCL Injection, USP, 100mg/5mL, 5 mL vials, Rx only, Manufactured by: Thymoorgan Pharmazie GmbH, Shiffgraben 2
Hazard: Defective Container: Customer complaints received of a crimp defect while removing the flip-cap during use.
June 24, 2020DrugsFDA
PD-Rx Pharmaceuticals, Inc. recalls metFORMIN HCL ER USP 500 mg, a) 30 tablets (NDC: 43063-428-30); b) 60 tablets (NDC: 43063-428-60); c) 90 tablets (NDC: 4
Hazard: CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level
June 24, 2020DrugsFDA
AVKARE Inc. recalls Metformin Hydrochloride Extended-Release Tablets, USP 500 mg, a) 50 count (NDC 50268-531-15); b) 90 count (NDC 42291-610
Hazard: CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level
June 24, 2020DrugsFDA
AVKARE Inc. recalls Metformin Hydrochloride Extended-Release Tablets, USP 750 mg a) 90 count (NDC 42291-611-90) b) 180 count (NDC 42291-611-
Hazard: CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level
June 24, 2020DrugsFDA
Apotex Inc. recalls Metformin Hydrochloride Extended-Release Tablets, USP 500 mg, 100 count bottles, Rx Only Manufactured by: Apotex, Inc. T
Hazard: CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above acceptable intake levels
June 17, 2020DrugsFDA
Akorn, Inc. recalls Prednisolone Sodium Phosphate Oral Solution, 5 mg/5 mL, 120 mL Bottle, Rx only, HI-TECH PHARMACAL CO., INC., Amityville,
Hazard: Discoloration: Out of Specification (OOS) result for APHA Color Test.
June 17, 2020DrugsFDA
Pfizer Inc. recalls Unasyn (ampicillin sodium/sulbacatam) for injection, 1.5 g* per vial, Rx Only, 10 vials/carton, Made in Italy Distribute
Hazard: Presence of Particulate Matter: particulate matter identified after reconstitution.
June 17, 2020DrugsFDA
QuVa Pharma, Inc. recalls oxyTOCIN 30 Units/500 mL (0.06 Units/mL) added to 0.9% Sodium Chloride Injection for IV Use, Rx only, QuVa Pharma 1075 W
Hazard: Subpotent drug - Product did not contain drug.
June 17, 2020DrugsFDA
Fresenius Kabi USA, LLC recalls Ketorolac Tromethamine Injection, USP, 60 mg per 2 mL (30 mg per mL), packaged in 2 mL Single Dose Vials (NDC 63323-162-
Hazard: Presence of Particulate Matter - found in reserve sample vials at the firm.
June 17, 2020DrugsFDA
Fresenius Kabi USA, LLC recalls Ketorolac Tromethamine Injection, USP, 30 mg per mL, packaged in 1 mL Single Dose Vials (NDC 63323-162-00); 25 x 1 mL Si
Hazard: Presence of Particulate Matter - found in reserve sample vials at the firm.
June 17, 2020DrugsFDA
American Health Packaging recalls Doxycycline Hyclate Tablets, USP, 100 mg, 30 Tablets per carton (3 x 10), Rx only, Distributed by: American Health Packa
Hazard: Failed dissolution specification - dissolution results of 59% (spec. NLT 85%) at the 24 month time point (end of shelf life).
June 17, 2020DrugsFDA
UNICHEM PHARMACEUTICALS USA INC recalls Clonidine Hydrochloride Tablets, USP 0.1 mg 100-count bottles, Rx only, Manufactured by: Unichem Laboratories LTD. Piler
Hazard: Failed Impurities/Degradation Specifications: potential migration of benzophenone at very low level into the product from container.
June 17, 2020DrugsFDA
Lupin Pharmaceuticals Inc. recalls Lisinopril Tablets, USP, 5 mg, Rx Only, 1000-count bottle, Manufactured for: Lupin Pharmaceuticals Inc., Baltimore, MD 2
Hazard: Product Mix Up: Lisinopril 10 mg tablets were found in Lisinopril 5 mg 1000-count bottle.
June 10, 2020DrugsFDA
Torrent Pharma Inc. recalls Carbamazepine Tablets, USP 200 mg, packaged in a 500-count bottle, Rx only, Manufactured by: Torrent Pharmaceuticals Ltd
Hazard: Failed Dissolution Specifications
June 10, 2020DrugsFDA
Acella Pharmaceuticals, LLC recalls NP Thyroid 90, Thyroid Tablets, USP, 1 & 1/2 grain (90 mg), 100-count bottles, Rx Only, Manufactured For: Acella Pharmac
Hazard: Superpotent Drug.
June 10, 2020DrugsFDA
Acella Pharmaceuticals, LLC recalls NP Thyroid 60, Thyroid Tablets, USP, 1 grain (60 mg), 100-count bottles, Rx Only, Manufactured For: Acella Pharmaceutica
Hazard: Superpotent Drug.
June 10, 2020DrugsFDA
Acella Pharmaceuticals, LLC recalls NP Thyroid 30, Thyroid Tablets, USP, 1/2 grain (30 mg), 100-count bottles, Rx Only, Manufactured For: Acella Pharmaceuti
Hazard: Superpotent Drug.
June 10, 2020DrugsFDA
AVKARE Inc. recalls Lamotrigine Tablets, USP, 150 mg, Rx Only, a) 60 count Bottle, NDC 42291-368-60, b) 500 count Bottle, NDC 42291-368-50,
Hazard: Presence of Foreign Substance consistent with granules from desiccant packs used during storage
June 10, 2020DrugsFDA
The Harvard Drug Group recalls Doxycycline Hyclate Tablets, USP, 100 mg, packaged in a) 3x10 unit dose cartons (NDC 0904-0430-04) and b) 5 x 10 unit do
Hazard: Failed Dissolution Specification: The dissolution test at the 24 month time point (end of shelf life) yielded an out-of-specification result.
June 10, 2020DrugsFDA
Teva Pharmaceuticals USA recalls Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate Tablets ( Mixed A
Hazard: Some bottles may contain mixed strengths of the product.
June 10, 2020DrugsFDA
Teva Pharmaceuticals USA recalls Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate Tablets ( Mixed A
Hazard: Some bottles may contain mixed strengths of the product.
June 10, 2020DrugsFDA
Teva Pharmaceuticals USA recalls Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate Tablets ( Mixed A
Hazard: Some bottles may contain mixed strengths of the product.
June 10, 2020DrugsFDA
TRIOVA PHARMACEUTICALS LLC recalls Estriol USP Micronized 5 G, Rx only, Triova 115 W 3rd Street Suite 720 Tulsa, OK 74103, NDC 71092-9977-02
Hazard: Failed impurities/ degradation specifications: Out of specification for organic impurities.