FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
WHOLE FOODS MARKET
- Product
- 365 Everyday Value Brand White Corn Chips, Salted NET WT 20…
- Reason
- Product may contain undeclared milk.
- Published
- October 17, 2018
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass 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
by Otsuka Pharmaceutical Development & Commercialization, Inc.
- Reason
- 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.
- Published
- October 10, 2018
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass 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
by Otsuka Pharmaceutical Development & Commercialization, Inc.
- Reason
- 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.
- Published
- October 10, 2018
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass 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.
by Endo Pharmaceuticals, Inc.
- Reason
- 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."
- Published
- October 10, 2018
- Distribution
- Nationwide
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FDA Recall
Terminated
Historical recordClass 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
by Dr. Reddy's Laboratories, Inc.
- Reason
- Failed stability specifications - An out of specification result was observed for the test parameter : composition of Nystatin during stability testing.
- Published
- October 10, 2018
- Distribution
- Nationwide
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FDA Recall
Terminated
Historical recordClass 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
by Sichuan Friendly Pharmaceutical Co.,Ltd.
- Reason
- CGMP Deviations: Thyroid Powder has inconsistent levels of the active ingredients levothyroxine and liothyronine.
- Published
- October 10, 2018
- Distribution
- Nationwide
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FDA Recall
Terminated
Historical recordClass 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
by Pfizer Inc.
- Reason
- 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.
- Published
- October 10, 2018
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass 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
by BioLyte Laboratories, LLC
- Reason
- 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.
- Published
- October 10, 2018
- Distribution
- Nationwide
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FDA Recall
Terminated
Historical recordClass II
Clozapine Orally Disintegrating Tablets, 12.5 mg, 100-count bottles, Rx only, Teva Pharmaceuticals USA, Inc., North Wales, PA 19454, NDC 0093-5416-01 Yellow, round, flat-faced, beveled-edge, unscored tablet. Debossed with 13 on one side and plain on the other side.
by Teva Pharmaceuticals USA
- Reason
- Failed Disintegration Specifications: Out-of-specification disintegration test result obtained during routine stability testing.
- Published
- October 10, 2018
- Distribution
- Nationwide
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FDA Recall
Terminated
Historical recordClass 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
by Boehringer Ingelheim Pharmaceuticals, Inc.
- Reason
- Cross Contamination With Other Products:
- Published
- October 3, 2018
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass 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.
by Baxter Healthcare Corporation
- Reason
- Superpotent Drug: High out of specification results for levofloxacin resulting in increased concentration of solution.
- Published
- October 3, 2018
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass 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.
by Hetero Labs Limited Unit V
- Reason
- Discoloration: A complaint was received from a pharmacist for the presence of blue specks on tablets.
- Published
- October 3, 2018
- Distribution
- Nationwide
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FDA Recall
Terminated
Historical recordClass 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
by Noven Pharmaceuticals, Inc.
- Reason
- Defective Delivery System: out of specification results for shear, an attribute related to the adhesive properties of the transdermal patches.
- Published
- October 3, 2018
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass 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
by Noven Pharmaceuticals, Inc.
- Reason
- Defective Delivery System: out of specification results for shear, an attribute related to the adhesive properties of the transdermal patches.
- Published
- October 3, 2018
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass 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
by Noven Pharmaceuticals, Inc.
- Reason
- Defective Delivery System: out of specification results for shear, an attribute related to the adhesive properties of the transdermal patches.
- Published
- October 3, 2018
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass 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
by Noven Pharmaceuticals, Inc.
- Reason
- Defective Delivery System: out of specification results for shear, an attribute related to the adhesive properties of the transdermal patches.
- Published
- October 3, 2018
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
Historical recordClass 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
by Hetero Labs Limited Unit V
- Reason
- Labeling: Label Mix-Up - One lot labeled Montelukast Sodium Tablets 10 mg tablets may contain 90 tablets of Losartan Potassium 50 mg.
- Published
- October 3, 2018
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass III
Swire Coca Cola USA
- Product
- Caffeine-Free Barq s Root Beer 12 Pack, 12 oz cans
- Reason
- Recalling Caffeine-Free Barq s Root Beer 12 Pack due to mislabeling.
- Published
- October 3, 2018
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Swanson Health Products, Inc
- Product
- Swanson Ultra, Himalayan Crystal Salt, #SWU403, Net Wt. 35.2…
- Reason
- Himalayan Crystal Salt may contain metal wire pieces.
- Published
- October 3, 2018
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass 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
by LUPIN SOMERSET
- Reason
- 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.
- Published
- September 26, 2018
- Distribution
- Nationwide
View recall →
Recall records are summarized from official FDA and USDA sources. Notices may be updated, reclassified, terminated, or withdrawn. Always review the linked official notice for the most current instructions.
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