FDA Recall
Terminated
Historical recordClass II
Glutathione 200mg/mL, 10mL amber vial, Rx only, Partell Specialty Pharmacy, 5835 S. Eastern Ave. #101, Las Vegas, NV 89119 (702) 791-3800
by Partell Specialty Pharmacy
- Reason
- Lack of Assurance Sterility: Firm is recalling various drug products due to a non-approved method of sterilization.
- Published
- April 25, 2018
- Distribution
- NV only
View recall →
FDA Recall
Terminated
Historical recordClass II
Amantadine HCl Capsules, USP, 100 mg, 50 Capsules (5x10) Unite Dose, Rx Only, Manufactured for: AvKARE Inc. Pulaski, TN 38478 --- NDC 50268-069-15
by AVKARE Inc.
- Reason
- Failed Dissolution Specifications
- Published
- April 25, 2018
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
Triamterene and Hydrochlorothiazide Tablets, USP, 75 mg/50 mg, 500-count bottles, Rx only, Manufactured by Sandoz, Inc., Princeton, NJ 08540, NDC 0781-5067-05.
by Sandoz Incorporated
- Reason
- Cross Contamination With Other Products: presence of unrelated ingredients (i.e. traces of Lisinopril, Mannitol, Iron, Calcium and Phosphorous).
- Published
- April 25, 2018
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
WipeEssentials Wet Wipes (benzalkonium chloride 0.13%), 30-count pouches, Dist. by Diamond Wipes Int'l, Inc., Chino, CA 91710, UPC 7 66670 03988 6.
by Diamond Wipes International, Inc.
- Reason
- CGMP Deviations: finished products were manufactured with poor quality water.
- Published
- April 25, 2018
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Daytrana (methylphenidate transdermal system) Delivers 10 mg over 9 hours (1.1 mg/hr) Contains: 30 Patches Rx Only NDC 68968-5552-3 Manufactured for Noven Therapeutics, LLC., Miami, FL 33186 by Noven Pharmaceuticals, Inc. Miami, FL 33186 1-877-567-7857
by Noven Pharmaceuticals, Inc.
- Reason
- Defective Delivery System: Out of specification for adhesive transfer.
- Published
- April 25, 2018
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
Nutrizone LLC
- Product
- Pain Out Thai Kratom all packages, all quantities
- Reason
- Dietary supplements have the potential to be contaminated with Salmonella.
- Published
- April 25, 2018
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
Nutrizone LLC
- Product
- Pain Out Maeng Da Kratom all packages, all quantities
- Reason
- Dietary supplements have the potential to be contaminated with Salmonella.
- Published
- April 25, 2018
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
Nutrizone LLC
- Product
- Pain Out Green Malay Kratom all packages, all quantities
- Reason
- Dietary supplements have the potential to be contaminated with Salmonella.
- Published
- April 25, 2018
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
Nutrizone LLC
- Product
- Nirvanio Special Reserve Kratom all packages, all quantities
- Reason
- Dietary supplements have the potential to be contaminated with Salmonella.
- Published
- April 25, 2018
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
Nutrizone LLC
- Product
- Nirvanio Maeng Da Kratom all packages, all quantities
- Reason
- Dietary supplements have the potential to be contaminated with Salmonella.
- Published
- April 25, 2018
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
Nutrizone LLC
- Product
- Nirvanio Green Malay Kratom all packages, all quantities
- Reason
- Dietary supplements have the potential to be contaminated with Salmonella.
- Published
- April 25, 2018
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
Nutrizone LLC
- Product
- Nirvanio Bali Kratom all packages, all quantities
- Reason
- Dietary supplements have the potential to be contaminated with Salmonella.
- Published
- April 25, 2018
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
Nutrizone LLC
- Product
- Cali Thai Kratom all packages, all quantities
- Reason
- Dietary supplements have the potential to be contaminated with Salmonella.
- Published
- April 25, 2018
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
Nutrizone LLC
- Product
- Cali Maeng Da Kratom all packages, all quantities
- Reason
- Dietary supplements have the potential to be contaminated with Salmonella.
- Published
- April 25, 2018
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
Nutrizone LLC
- Product
- Cali Green Malay Kratom all packages, all quantities
- Reason
- Dietary supplements have the potential to be contaminated with Salmonella.
- Published
- April 25, 2018
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass III
Funky Chunky LLC
- Product
- funky chunky Chocolate Pretzels. Pretzels, Caramel, Chocola…
- Reason
- Chocolate Pretzels are being recalled because the pecan pieces may contain undeclared tree nuts and peanuts.
- Published
- April 25, 2018
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Swire Coca Cola USA
- Product
- Dr. Pepper Est. 1885 Diet, 20 FL Oz (1.25 PT), 591 mL
- Reason
- Swire Coca Cola is recalling certain Diet Dr Pepper bottle due to the potential presence of foreign material.
- Published
- April 25, 2018
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Divinity Product Distribution LLC
- Product
- Kratom powder labeled in the following ways 1) Enhance Your…
- Reason
- The firm's dietary supplement products contain kratom (Mitragyna speciosa), a new dietary ingredient for which there is inadequate information to provide reasonable assurance that such ingredient does not present a significant or unreasonable risk of illness or injury;
- Published
- April 25, 2018
- Distribution
- Product distributed to the following US…
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Divinity Product Distribution LLC
- Product
- Kratom capsules labeled in the following ways: 1) Divinity K…
- Reason
- The firm's dietary supplement products contain kratom (Mitragyna speciosa), a new dietary ingredient for which there is inadequate information to provide reasonable assurance that such ingredient does not present a significant or unreasonable risk of illness or injury;
- Published
- April 25, 2018
- Distribution
- Product distributed to the following US…
View recall →
FDA Recall
Terminated
Historical recordClass III
Decitabine for Injection, 50mg per vial, Rx only, Manufactured by: Cipla Ltd., Verna Goa, India, Manufactured for: Cipla USA, Inc., 1560 Sawgrass Corporate Parkway, Suite 130, Sunrise, FL 33323, NDC 69097-285-37
by InvaGen Pharmaceuticals, Inc.
- Reason
- Failed impurities/degradation specifications: Failure to water content and impurity
- Published
- April 18, 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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