Drug and pharmaceutical recalls

17728 federal recalls on file. Federal recalls for prescription drugs, OTC medications, supplements, and pharmaceuticals. Sourced from the FDA and translated into plain English.

2018-10-17FDA-DrugXiromed LLCClass III
Altavera Levonorgestrel and Ethinyl Estradiol Tablets, USP 0.15 mg and 0.03 mg, Rx only, 3 tablet dispensers x 28 tablets. Manufactured by Laboratories Leon Farma S.A., Spain, for Xiromed, LLC., Florham Park, NJ 07932. Product of Spain NDC 70700-116-85 (I unit x 28 tablets 70700-116-84)
Labeling: Not Elsewhere Classified: mislabeling of the Altavera generic name on the packaging component that may cause confusion.
2018-10-17FDA-DrugPfizer Inc.Class II
Magnesium Sulfate in Water for Injection (0.325 mEq Mg++/mL) 40 mg/mL, 20 g Total, 500 mL Single-Dose Container bag, Rx only, Hospira, Inc. Lake Forest, IL 60045 USA, NDC 0409-6729-03.
Correct Labeled Product Mispack: confirmed report involving a single unit of properly labeled Heparin in 0.45% Sodium Chloride for Injection (NDC 0409-7651-03, Lot 87903FW) that was found inside a case of Magnesium Sulfate in Water for Injection.
2018-10-17FDA-DrugSyntec Pharma CorpClass II
THYROID POWDER USP (Levothyroxine labeled range of 34.2-41.8mcg/grain; Liothyroine (correct spelling Liothyronine): labeled range of 8.1-9.9mcg/grain) active pharmaceutical ingredient; 25 KG bag, Rx Compounding only, Manu By: Sichuan Friendly Pharmaceutical Co., Ltd., No. 680 Hongpai Road, Neijiang, sichuan 641000, china; Distributed: Syntec Pharma Corp., 96 Gazza Blvd., Farmingdale NY 11735, CAS No. 50809-32-0
CGMP Deviations: Recall notice received from supplier that Thyroid Powder has inconsistent levels of the active ingredients levothyroxine and liothyronine.
2018-10-17FDA-DrugSyntec Pharma CorpClass II
THYROID POWDER USP, Full Strength (Levothyroxine labeled range of 103-125mcg/grain; Liothyroine (correct spelling Liothyronine): labeled range of 24.3-29.7mcg/grain) active pharmaceutical ingredient; 5 KG bag, Rx Compounding only, Manu By: Sichuan Friendly Pharmaceutical Co., Ltd., No. 680 Hongpai Road, Neijiang, sichuan 641000, china; Distributed: Syntec Pharma Corp., 96 Gazza Blvd., Farmingdale NY 11735, CAS No. 50809-32-0
CGMP Deviations: Recall notice received from supplier that Thyroid Powder has inconsistent levels of the active ingredients levothyroxine and liothyronine.
2018-10-17FDA-DrugInvaGen Pharmaceuticals, Inc.Class III
Amlodipine Besylate USP 10 mg Tablets, 1000-count bottles, Rx Only, Manufactured by: Cipla Ltd., Verna Goa, India, Manufactured for: Cipla USA, Inc. 1560 Sawgrass Corporate Parkway, Suite 130, Sunrise FL 33323 UPC 369097128159, NDC 69097-128-15
Subpotent Drug: One lot of product does not meet the product specification for Assay test at 3 month long term stability condition.
2018-10-17FDA-DrugJubilant Cadista Pharmaceuticals, Inc.Class II
Pantoprazole Sodium Delayed-Release Tablets, USP, 40 mg*, 90-count bottle, Rx only, Manufactured by: Jubilant Generics Ltd., Roorkee - 247661, India; Marketed by: Jubilant Cadista Pharmaceuticals Inc., Salisbury, MD 21801; NDC 59746-284-90.
Discoloration: Presence of dark discoloration or brown spots on the edges of the tablets.
2018-10-17FDA-DrugPfizer Inc.Class II
Glipizide XL (glipizide) extended-release tablets 5 mg 500-tablet bottle, Rx only Distributed by: Greenstone LLC. Peapack, NJ 07977 --- NDC 59762-0541-2
CGMP Deviations; rejected product was used to manufacture final bulk lot
2018-10-17FDA-DrugAlkano Chemicals, IncClass II
Thyroid powder, 4.5 kg foil bag, 5x1 kg foil bags packed in 25 Kg Fiber Drum, Thyroid Powder 25kg/drum, US Pharmacopoeia, Sichuan Friendly Pharmaceutical Co., LTD, Production Address: No. 680, Hongpai Road, Dongxing District, Neijiang City Sichuan, China Tel:+886 832 2240082/2240298, NDC 7807-0170-11
CGMP Deviations: Recall notice received from supplier that Thyroid Powder has inconsistent levels of the active ingredients levothyroxine and liothyronine.
2018-10-10FDA-DrugOtsuka Pharmaceutical Development & Commercialization, Inc.Class III
treatNOW ABILIFY (aripiprazole) / ABILIFY MAINTENA 400-mg (aripiprazole) for extended release injectable suspension. Kit contents 2 packs Abilify Tablets 10 mg (14 day supply) plus 1 Abilfy Maintena Vial Kit.Rx only. Distributed and Marketed by: Otsuka America Pharmaceutical, Inc. Rockville, MD 20850 USA Marketed by: Lundbleck, Deerfield, IL 60015 USA Bar Code VialKit-59148-10Tabs-02
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.
2018-10-10FDA-DrugOtsuka Pharmaceutical Development & Commercialization, Inc.Class III
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
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.
2018-10-10FDA-DrugEndo Pharmaceuticals, Inc.Class I
robaxin-750 (methocarbamol tablets, USP), 750 mg, 100-count bottle, Rx Only, Distributed by: Endo Pharmaceuticals Inc., Malvern, PA 19355; Manufactured by: Kremers Urban Pharmaceuticals Inc., a subsidiary of Lannett Company, Inc., Seymour, IN 47274; NDC 52244-449-10.
Labeling: Incorrect Instructions: Dosage information on the immediate container label incorrectly states "Two to four tablets four times daily." rather than the correct dosage of "Two tablets three times daily."
2018-10-10FDA-DrugDr. Reddy's Laboratories, Inc.Class II
Nystatin and Triamcinolone Acetonide Cream, USP, 100,000 units/gm & 1 mg/gm, packaged in a) 15 g tube (NDC 43598-431-44), b) 30 g tube (NDC 43598-431-30), c) 60 g tube (NDC 43598-431-60), Rx only, Distributor: Dr. Reddy's Laboratories, Inc. 107 College Road East, Princeton, NJ - 08540 Rx Only Made in India
Failed stability specifications - An out of specification result was observed for the test parameter : composition of Nystatin during stability testing.
2018-10-10FDA-DrugSichuan Friendly Pharmaceutical Co.,Ltd.Class II
Thyroid Powder 25kg/drum, US Pharmacopoeia, Sichuan Friendly Pharmaceutical Co., LTD, Production Address: No. 680, Hongpai Road, Dongxing District, Neijiang City Sichuan, China Tel:+886 832 2240082/2240298. NDC 7807-0170-11
CGMP Deviations: Thyroid Powder has inconsistent levels of the active ingredients levothyroxine and liothyronine.
2018-10-10FDA-DrugPfizer Inc.Class II
Elelyso (taliglucerase alfa) for injection, 200 units/vial, single-use vial, Rx only, Distributed by Pfizer Labs, Division of Pfizer Inc, NY, NY 10017, NDC 0069-0106-01
Lack of assurance of sterility -Reports of loose metal ferrule crimps on vials for injection. The entire cap either lifted or dislodged while attempting to flip off the orange color plastic button.
2018-10-10FDA-DrugBioLyte Laboratories, LLCClass II
NeoRelief for Muscle Cramping & Restlessness Homeopathic Topical Gel, packaged in a) 4 ml sample packs and b) Net Wt. 2.0 oz (56.7g) bottles, BioLyte Laboratories - Grand Rapids, MI 49534, NDC 58368-002-02
CGMP Deviations: finished product produced with active ingredients recalled by the manufacturer, King Bio Inc., due to water contamination issues that could potentially affect the quality of this product.
2018-10-10FDA-DrugTeva Pharmaceuticals USAClass II
Stop using Teva Clozapine 12.5 mg tablets
Failed Disintegration Specifications: Out-of-specification disintegration test result obtained during routine stability testing.
2018-10-03FDA-DrugBoehringer Ingelheim Pharmaceuticals, Inc.Class II
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
Cross Contamination With Other Products:
2018-10-03FDA-DrugBaxter Healthcare CorporationClass III
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.
Superpotent Drug: High out of specification results for levofloxacin resulting in increased concentration of solution.
2018-10-03FDA-DrugHetero Labs Limited Unit VClass II
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.
Discoloration: A complaint was received from a pharmacist for the presence of blue specks on tablets.
2018-10-03FDA-DrugHetero Labs, Ltd. - Unit IIIClass III
Fenofibrate Tablets, USP 145 mg, 90-count bottles, Rx only, Manufactured for: Camber Pharmaceuticals, Inc. Piscataway, NJ, 08854, NDC 31722-596-90
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.
2018-10-03FDA-DrugNoven Pharmaceuticals, Inc.Class II
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
Defective Delivery System: out of specification results for shear, an attribute related to the adhesive properties of the transdermal patches.
2018-10-03FDA-DrugNoven Pharmaceuticals, Inc.Class II
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
Defective Delivery System: out of specification results for shear, an attribute related to the adhesive properties of the transdermal patches.
2018-10-03FDA-DrugNoven Pharmaceuticals, Inc.Class II
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
Defective Delivery System: out of specification results for shear, an attribute related to the adhesive properties of the transdermal patches.
2018-10-03FDA-DrugNoven Pharmaceuticals, Inc.Class II
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
Defective Delivery System: out of specification results for shear, an attribute related to the adhesive properties of the transdermal patches.
2018-10-03FDA-DrugDr. Reddy's Laboratories, Inc.Class III
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
Failed Impurities/Degradation Specifications: OOS for unknown impurities.
2018-10-03FDA-DrugDr. Reddy's Laboratories, Inc.Class III
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
Failed Impurities/Degradation Specifications: OOS for unknown impurities.
2018-10-03FDA-DrugHetero Labs Limited Unit VClass I
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
Labeling: Label Mix-Up - One lot labeled Montelukast Sodium Tablets 10 mg tablets may contain 90 tablets of Losartan Potassium 50 mg.
2018-09-26FDA-DrugLUPIN SOMERSETClass III
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
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.
2018-09-26FDA-DrugInvaGen Pharmaceuticals, Inc.Class III
Bupropion Hydrochloride ER Tablets, USP 150 mg, packaged in a) 90-count bottle (NDC 69097-875-05), Manufactured for: Cipla USA Inc., 1560 Sawgrass Corporate Parkway, Suite 130 Sunrise, FL 33323 b) 90-count bottle (NDC 68001-322-05), For BluePoint Laboratories, Rx only, Manufactured by: InvaGen Pharmaceuticals, Inc. (a subsidiary of Cipla Ltd.) Hauppauge, NY 11788
Failed impurities/ degradation specifications: Out-of-specification results were observed in the meta-chlorobenzoic acid impurity in batches 18 months or older from date of manufacture in the 90 count bottle size.
2018-09-26FDA-DrugJubilant Cadista Pharmaceuticals, Inc.Class III
MethylPREDNISolone Tablets, USP, 4 mg, 21-count blister pack. Rx Only. Jubilant Cadista Pharmaceuticals Inc. Salisbury, MD NDC 59746-001-03
Failed Stability Specifications: An out-of-specification result was obtained during 18-month stability testing for assay.

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