FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
Rucker's Wholesale & Service Co., Inc.
- Product
- Cajun Hot Mix 6 OZ. packaged in clear plastic bags with stic…
- Reason
- Sunflower kernels in this product are contaminated with Listeria Monocytogenes per the original supplier, SunOpta.
- Published
- July 27, 2016
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
Rucker's Wholesale & Service Co., Inc.
- Product
- HC SUNFLOWER KERNEL 3 OZ. packaged in a clear plastic bag wi…
- Reason
- Sunflower kernels in this product are contaminated with Listeria Monocytogenes per the original supplier, SunOpta.
- Published
- July 27, 2016
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
Oxycodone HCl, Oral Solution USP, 5 mg/5 mL, 15 mL bottles, Rx only, Boehringer Ingelheim Roxane, Inc., Columbus, OH --- NDC 0054-0390-41
by West-Ward Columbus Inc
- Reason
- Failed Impurities/Degradation Specification; 9 month stability
- Published
- July 20, 2016
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Daytrana (methylphenidate transdermal system) Transdermal Patch, 30 mg over 9 hours (3.3 mg/hr), packaged in 30-count patches per box, Rx only, Manufactured by Noven Therapeutics, LLC, Miami, FL 33186; By Noven Pharmaceuticals, Inc., Miami, FL 33186, NDC 68968-5555-3.
by Noven Pharmaceuticals, Inc.
- Reason
- Defective Delivery System: Out of Specification (OOS) results for the mechanical peel force (MPF) and z-statistic value which relates to the patients and caregiver ability to remove the release liner from the patch adhesive prior to administration.
- Published
- July 20, 2016
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Daytrana (methylphenidate transdermal system) Transdermal Patch, 20 mg over 9 hours (2.2 mg/hr), packaged in 30-count patches per box, Rx only, Manufactured by Noven Therapeutics, LLC, Miami, FL 33186; By Noven Pharmaceuticals, Inc., Miami, FL 33186, NDC 68968-5554-3.
by Noven Pharmaceuticals, Inc.
- Reason
- Defective Delivery System: Out of Specification (OOS) results for the mechanical peel force (MPF) and z-statistic value which relates to the patients and caregiver ability to remove the release liner from the patch adhesive prior to administration.
- Published
- July 20, 2016
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Daytrana (methylphenidate transdermal system) Transdermal Patch, 15 mg over 9 hours (1.6 mg/hr), packaged in 30-count patches per box, Rx only, Manufactured by Noven Therapeutics, LLC, Miami, FL 33186; By Noven Pharmaceuticals, Inc., Miami, FL 33186, NDC 68968-5553-3.
by Noven Pharmaceuticals, Inc.
- Reason
- Defective Delivery System: Out of Specification (OOS) results for the mechanical peel force (MPF) and z-statistic value which relates to the patients and caregiver ability to remove the release liner from the patch adhesive prior to administration.
- Published
- July 20, 2016
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
Duloxetine Delayed-Release Capsules, USP, 30 mg, 30-count bottles, Rx only, Manufactured by Apotex Inc, Toronto, Ontario M9L 1T9, Manufactured for Apotex Corp. Weston Florida 33326, NDC 60505-2996-3; UPC # 360505299638.
by Apotex Scientific, Inc
- Reason
- Failed Dissolution Specification: Out of specification dissolution results when testing product stability.
- Published
- July 20, 2016
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
Duloxetine Delayed-Release Capsules, USP, 60 mg, 30-count bottles, Rx only, Manufactured by Apotex Inc, Toronto, Ontario M9L 1T9, Manufactured for Apotex Corp. Weston Florida 33326, NDC 60505-2997-3; UPC # 360505299737;
by Apotex Scientific, Inc
- Reason
- Failed Dissolution Specification: Out of specification dissolution results when testing product stability.
- Published
- July 20, 2016
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
Duloxetine Delayed-Release Capsules, USP, 20 mg, 60-count bottles, Rx only, Manufactured by Apotex Inc, Toronto, Ontario M9L 1T9, Manufactured for Apotex Corp. Weston Florida 33326, NDC 60505-2995-6; UPC # 360505299560;
by Apotex Scientific, Inc
- Reason
- Failed Dissolution Specification: Out of specification dissolution results when testing product stability.
- Published
- July 20, 2016
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Diazepam Injection USP 10mg/2mL (5 mg/mL, 2 mL), Rx only, Hospira Inc. Lake Forest, IL 60045, NDC 0409-1273-32
by Hospira Inc.
- Reason
- Crystallization: Product contains particulate identified to be crystallized active ingredient.
- Published
- July 20, 2016
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
FUQINGSONG RELIEF CREAM (Flucinonide Ointment), packaged in 50-count individually labeled pieces Net Wt. 0.32oz (10g) within a box, MANUFACTURED BY: TIANJIN MAEDICAL & PHARMACEUTICAL CO., LTD. ADDREST: 96 BAWAEI ROAD, HEDONG COUNTY, TIANJIN CITY, remaining labeling contains Chinese characters.
by Murray International Trading Co., Inc.
- Reason
- Marketed Without An Approved NDA/ANDA: Products marked as dietary supplements have labeling that bears drug/disease claims, making them unapproved drugs.
- Published
- July 20, 2016
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Te Xiao BaiNeiTing Herbal Supplement (Naphazoline HCl Solution 0.1%) liquid, Net Wt. 15ml, packaged in a bottle within a box, Produced by: Good Harvests (Asia) Trading Co., Ltd, Imported by Murray Int'l Trading Co., Inc. New York, NY 10013, UPC 7 67533 86115 6, remaining labeling contains Chinese characters.
by Murray International Trading Co., Inc.
- Reason
- Marketed Without An Approved NDA/ANDA: Products marked as dietary supplements have labeling that bears drug/disease claims, making them unapproved drugs.
- Published
- July 20, 2016
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
PING ON OINTMENT RELIEF FOR MUSCULAR PAIN, packaged in a packet of 12-count 8gm containers within a box, PING ON OINTMENT CO LTD, PING ON OINTMENT INTERNATIONAL LTD, 149 Queen's Road West, Hong Kong, UPC 8 33679 00001 5, remaining labeling contains Chinese characters.
by Murray International Trading Co., Inc.
- Reason
- Marketed Without An Approved NDA/ANDA: Products marked as dietary supplements have labeling that bears drug/disease claims, making them unapproved drugs.
- Published
- July 20, 2016
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
FARSER KAI YEUNG PILL, packaged in a bottle within a box, Made in The Peoples Republic of China, remaining labeling contains Chinese characters.
by Murray International Trading Co., Inc.
- Reason
- Marketed Without An Approved NDA/ANDA: Products marked as dietary supplements have labeling that bears drug/disease claims, making them unapproved drugs.
- Published
- July 20, 2016
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
WUPOOSER KAI YEUNG PILL, packaged in a bottle within a box, Made in The Peoples Republic of China, remaining labeling contains Chinese characters.
by Murray International Trading Co., Inc.
- Reason
- Marketed Without An Approved NDA/ANDA: Products marked as dietary supplements have labeling that bears drug/disease claims, making them unapproved drugs.
- Published
- July 20, 2016
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
GASTRODIA CAPSULES, packaged in 30-count bottles within a box, LANZHOU MANUFACTORY OF CHINA. GANSU CHINA; remaining labeling contains Chinese characters.
by Murray International Trading Co., Inc.
- Reason
- Marketed Without An Approved NDA/ANDA: Products marked as dietary supplements have labeling that bears drug/disease claims, making them unapproved drugs.
- Published
- July 20, 2016
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
PEKING NIU-HUANG CHIEH-TU-PIEN Tablets (Sugar Coated), packaged in 50-count bottles within a box, BEIJING TUNG JEN TANG. BEIJING CHINA; remaining labeling contains Chinese characters.
by Murray International Trading Co., Inc.
- Reason
- Marketed Without An Approved NDA/ANDA: Products marked as dietary supplements have labeling that bears drug/disease claims, making them unapproved drugs.
- Published
- July 20, 2016
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
LARYNGITIS PILLS Herbal Supplement, packaged in 10-count packets containing 3 tubes per packet within a box, Produced by: Good Harvests (Asia) Trading Co., Ltd.; Imported by: Murray Int'l Trading Co., Inc., New York, NY 10013; UPC 7 67533 86925 1, remaining labeling contains Chinese characters.
by Murray International Trading Co., Inc.
- Reason
- Marketed Without An Approved NDA/ANDA: Products marked as dietary supplements have labeling that bears drug/disease claims, making them unapproved drugs.
- Published
- July 20, 2016
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Tien Ma Tou Tong Wan (Condensed pills), packaged in 100-count bottles within a box, Kwangchow First Chinese Medicine Factory, Kwangchow, China; remaining labeling contains Chinese characters.
by Murray International Trading Co., Inc.
- Reason
- Marketed Without An Approved NDA/ANDA: Products marked as dietary supplements have labeling that bears drug/disease claims, making them unapproved drugs.
- Published
- July 20, 2016
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
CROCODILE BILE PILL FOR ASTHMA, packaged in 100-count bottles within a box, remaining labeling contains Chinese characters.
by Murray International Trading Co., Inc.
- Reason
- Marketed Without An Approved NDA/ANDA: Products marked as dietary supplements have labeling that bears drug/disease claims, making them unapproved drugs.
- Published
- July 20, 2016
- 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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