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Prescription Drugs

💊 Drugs • 12,141 recalls

treatNOW ABILIFY (aripiprazole) and ABILIFY MAINTENA (aripiprazole) 400MG for extended release injectable suspension. Kit Contents: 2 packs ABILIFY Tablets 10mg (14 day supply) plus 1 ABILIFY MAINTENA Pre-filled Dual Chamber Syringe Kit. Rx only. Not for sale or reimbursement. Distributed and Marketed by: Otsuka America Pharmaceutical, Inc. Rockville, MD 20850. Marketed by: Deerfield, IL 60015 USA. Bar Code DCSKit-59148-10Tabs-01

Otsuka Pharmaceutical Development & Commercialization

Class I - Dangerous

Labeling Not Elsewhere Classified: Physician sample kits/cartons of treatNOW Abilify are mislabeled. Product name is misspelled, storage instructions are missing and contents of kits may be incorrectly labeled on the outer packaging of the co-packaged kit.

Sep 17, 2018 Prescription Drugs Nationwide View Details →

Minivelle (estradiol transdermal system) Patches, Delivers 0.025 mg/day, 8 count boxes, Rx only, Mfd. by: Noven Pharmaceuticals, Inc. Miami, Florida 33186 Dist. By: Noven Therapeutics, LLC. Miami, Florida 33186 --- NDC 68968-6625-8

Noven Pharmaceuticals

Class I - Dangerous

Defective Delivery System: out of specification results for shear, an attribute related to the adhesive properties of the transdermal patches.

Sep 7, 2018 Prescription Drugs Nationwide View Details →

Minivelle (estradiol transdermal system) Patches Delivers 0.1 mg/day, a) 2 count and b) 8 count boxes, Rx only, , Mfd. by: Noven Pharmaceuticals, Inc. Miami, Florida 33186 Dist. By: Noven Therapeutics, LLC. Miami, Florida 33186 --- NDC 68968-6610-8

Noven Pharmaceuticals

Class I - Dangerous

Defective Delivery System: out of specification results for shear, an attribute related to the adhesive properties of the transdermal patches.

Sep 7, 2018 Prescription Drugs Nationwide View Details →

Synjardy (empagliflozin and metformin hydrochloride) Tablets. 5 mg/1000 mg. Rx only. 180-count bottle. Distributed by: Boehinger Ingelheim (BI) Pharmaceuticals, Inc. Ridgefield, CT 06877. Made in Germany. Marketed by: BI Pharmaceuticals, Inc. Ridgefield, CT 06877 and Eli Lilly and Company Indianapolis IN 46285 NDC 0597-0175-18

Boehringer Ingelheim Pharmaceuticals

Class I - Dangerous

Cross Contamination With Other Products:

Sep 4, 2018 Prescription Drugs Nationwide View Details →

Montelukast Sodium Tablets, 10 mg*, 30-count bottles, Rx Only, By: Hetero, Hetero Labs Limited, Unit V, Polepally, Jadcherla, Mahaboob Nagar - 509 301, India, Manufactured for: Camber Pharmaceuticals, Inc., Piscataway, NJ 08854, NDC 31722-726-30.

Hetero Labs Limited Unit V

Class I - Dangerous

Discoloration: A complaint was received from a pharmacist for the presence of blue specks on tablets.

Aug 20, 2018 Prescription Drugs Nationwide View Details →

Zoledronic Acid Injection, 5 mg/100 mL (0.05 mg/mL) One 100ml Single-Dose Bottle, Rx Only. NOVAPLUS Mfd By: Gland Pharma Limited D.P. Pally - 500 043 India: Mfd. For: Dr. Reddy's Laboratories Limited Bachupally - 500 090 India. N+ and NOVAPLUS are registered trademarks of Vizient, Inc. NDC 43598-331-11

Dr. Reddy's Laboratories

Class I - Dangerous

Failed Impurities/Degradation Specifications: OOS for unknown impurities.

Sep 12, 2018 Prescription Drugs View Details →

Minivelle (estradiol transdermal system) Patches, Delivers 0.075 mg/day, 8 count boxes, Rx only, Mfd. by: Noven Pharmaceuticals, Inc. Miami, Florida 33186 Dist. By: Noven Therapeutics, LLC. Miami, Florida 33186 --- NDC 68968-6675-8

Noven Pharmaceuticals

Class I - Dangerous

Defective Delivery System: out of specification results for shear, an attribute related to the adhesive properties of the transdermal patches.

Sep 7, 2018 Prescription Drugs Nationwide View Details →

Zoledronic Acid Injection, 5mg/100 mL (0.05 mg/mL) 100ml vial, Rx Only. Mfd By: Gland Pharma Limited D.P. Pally - 500 043 India: Mfd. For: Dr. Reddy's Laboratories Limited Bachupally - 500 090 India. NDC 55111-688-52

Dr. Reddy's Laboratories

Class I - Dangerous

Failed Impurities/Degradation Specifications: OOS for unknown impurities.

Sep 12, 2018 Prescription Drugs View Details →

Montelukast Sodium Tablets 10 mg, 30-count bottle, Rx Only, By: Hetero Hetero Labs Limited, Unit V, Polepally, Jadcherla, Mahaboob Nagar - 509 301, India, Manfuactured for: Camber Pharmaceuticals, Inc. Piscataway, NJ 08854, NDC 31722-726-30

Hetero Labs Limited Unit V

Class I - Dangerous

Labeling: Label Mix-Up - One lot labeled Montelukast Sodium Tablets 10 mg tablets may contain 90 tablets of Losartan Potassium 50 mg.

Aug 15, 2018 Prescription Drugs Nationwide View Details →

Fenofibrate Tablets, USP 145 mg, 90-count bottles, Rx only, Manufactured for: Camber Pharmaceuticals, Inc. Piscataway, NJ, 08854, NDC 31722-596-90

Hetero Labs, Ltd. - Unit III

Class I - Dangerous

Presence of Foreign Tablet/Capsule: A foreign identified as Valacyclovir tablet 500 mg was co-mingled in a bottle containing Fenofibrate Tablets, USP 145 mg.

Sep 12, 2018 Prescription Drugs View Details →

Levofloxacin Injection in 5% Dextrose, 5 mg/mL, packaged in a) 50 mL (NDC 36000-046-24), b) 100 mL (NDC 36000-047-24), c) 150 mL (NDC 36000-048-24) Container bags, Rx only, Manufactured for: Claris Lifesciences Inc., North Brunswick, NJ 08902; By: Claris Injectables Ltd., Gujarat, India.

Baxter Healthcare

Class I - Dangerous

Superpotent Drug: High out of specification results for levofloxacin resulting in increased concentration of solution.

Sep 25, 2018 Prescription Drugs Nationwide View Details →

Minivelle (estradiol transdermal system) Patches, Delivers 0.05 mg/day, a) 2 count and 8 count boxes, Rx only, Mfd. by: Noven Pharmaceuticals, Inc. Miami, Florida 33186 Dist. By: Noven Therapeutics, LLC. Miami, Florida 33186 --- NDC 68968-6650-8

Noven Pharmaceuticals

Class I - Dangerous

Defective Delivery System: out of specification results for shear, an attribute related to the adhesive properties of the transdermal patches.

Sep 7, 2018 Prescription Drugs Nationwide View Details →

Skin Irritation & Itch Response Homeopathic Formula, 2 FL. OZ. (59.2 mL) per amber glass oral spray bottle, Distributed by Beaumont Bio-Med, Inc., Waukon, IA 52172; NDC 58066-7002-7

Beaumont Bio-med

Class I - Dangerous

CGMP Deviations: products manufactured by contract manufacturer under conditions that could result in possible microbial contamination.

Aug 31, 2018 Prescription Drugs Nationwide View Details →

Tizanidine HCl Tablets, USP 2mg, 150-count bottles, Rx Only, Mfd. By: Dr. Reddy's Laboratories Limited Srilakulam - 532 409 INDIA, NDC 55111-179-15, UPC 35511179153

Dr. Reddy's Laboratories

Class I - Dangerous

Presence of Foreign Tablets/Capsules: Glimepiride tablet was found in a bottle of Tinzadine Hcl Tablets .

Sep 4, 2018 Prescription Drugs Nationwide View Details →

Diarrhea Response Homeopathic Formula, 2 FL. OZ. (59.2 mL) per amber glass oral spray bottle, Distributed by Beaumont Bio-Med, Inc., Waukon, IA 52172; NDC 58066-7022-7

Beaumont Bio-med

Class I - Dangerous

CGMP Deviations: products manufactured by contract manufacturer under conditions that could result in possible microbial contamination.

Aug 31, 2018 Prescription Drugs Nationwide View Details →

Allergy & Hay Fever Relief Homeopathic Formula, 2 FL. OZ. (59.2 mL) per amber glass oral spray bottle, Distributed by Beaumont Bio-Med, Inc., Waukon, IA 52172; NDC 58066-7011-7

Beaumont Bio-med

Class I - Dangerous

CGMP Deviations: products manufactured by contract manufacturer under conditions that could result in possible microbial contamination.

Aug 31, 2018 Prescription Drugs Nationwide View Details →

Sinus Response Homeopathic Formula, 2 FL. OZ. (59.2 mL) per amber glass oral spray bottle, Distributed by Beaumont Bio-Med, Inc., Waukon, IA 52172; NDC 58066-7013-7

Beaumont Bio-med

Class I - Dangerous

CGMP Deviations: products manufactured by contract manufacturer under conditions that could result in possible microbial contamination.

Aug 31, 2018 Prescription Drugs Nationwide View Details →

Morphine Sulfate Extended-Release Tablets, 30 mg, 100-count bottle, Rx only, Manufactured by: Novel Laboratories, Inc. Somerset, NJ 08873, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, MD 21202, NDC 43386-541-01

LUPIN SOMERSET

Class I - Dangerous

Failed Impurities/Degradation Specifications: Morphine Sulfate Extended Release Tablets are being recalled due to out of Specification Result noticed for Morphinone Sulfate impurity during 3 month stability analysis and during retain testing.

Aug 23, 2018 Prescription Drugs Nationwide View Details →

Colds & Flu Response Homeopathic Formula, 2 FL. OZ. (59.2 mL) per amber glass oral spray bottle, Distributed by Beaumont Bio-Med, Inc., Waukon, IA 52172; NDC 58066-7012-7

Beaumont Bio-med

Class I - Dangerous

CGMP Deviations: products manufactured by contract manufacturer under conditions that could result in possible microbial contamination.

Aug 31, 2018 Prescription Drugs Nationwide View Details →

Lamotrigine Extended-Release Tablets, USP, 200 mg, 30 tablets per bottle, Rx Only, Manufactured in INDIA, For: TORRENT PHARMA INC., 150 Allen Road, Suite 102, Basking Ridge, NJ 07920. NDC: 13668-342-30

Torrent Pharma

Class I - Dangerous

Failed Dissolution Specifications: Out of Specification for Dissolution test (Buffer Stage) at the 5-hour time point during stability testing.

Sep 11, 2018 Prescription Drugs Nationwide View Details →

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