FDA Recall
Terminated
Historical recordClass II
Neutrogena deep clean purifying whipped foam cleanser, (Salicylic Acid 0.5%), aerosolized product in a can, NET WT. 5 OZ. (141 g) Distributed By: Johnson & Johnson Consumer Inc. Skillman, NJ 08558. UPC: 0 70501 10053 0
by Johnson & Johnson
- Reason
- Defective Container: products showed leakage (bubbles, foaming) of propellant and product from the container valve cup area.
- Published
- February 7, 2018
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Neutrogena Acne Proofing whipped foam cleanser, (Salicylic Acid 2%), aerosolized product in a can, NET WT. 5 OZ (141 g) , Distributed by Johnson & Johnson Consumer Inc. Skillman, NJ 08558, UPC 0 70501 11131 4
by Johnson & Johnson
- Reason
- Defective Container: products showed leakage (bubbles, foaming) of propellant and product from the container valve cup area.
- Published
- February 7, 2018
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
SPIRIVA HandiHaler (tiotropium bromide inhalation powder) 18 mcg/capsule (90 capsules (unit dose blisters) per box, Rx Only, Made in Germany, Distributed by: Boehringer Ingelheim (BI) Pharmaceuticals, Inc., Ridgefield, CT 06877, NDC 0597-0075-47
by Boehringer Ingelheim Pharmaceuticals, Inc.
- Reason
- Failed Stability Specifications
- Published
- February 7, 2018
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
Dollar General Corporation, Inc.
- Product
- Clover Valley¿ Iced Oatmeal Cookies NET WT 12 OZ (340 g) CON…
- Reason
- The firm received Ice Oatmeal Cookies that actually contain Coconut Macaroon Cookies. Product is being recalled due to mislabeling. Product contains both milk and tree nuts that are not listed in the ingredient statement.
- Published
- February 7, 2018
- Distribution
- Product was shipped to the following sta…
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Jarrow Formulas Inc
- Product
- Jarrow Formulas Liquid L-Carnitine; 16 fl oz. (475 ml) bott…
- Reason
- A higher than normal micro result was found at the six month time point for one lot of Liquid L-Carnitine.
- Published
- February 7, 2018
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass I
BodySlim Herbal Advanced technology & Strong formula capsules, 400 mg, 30-count bottle, Barcode: 9567153432481
by BotanicalNow
- Reason
- Marketed without an approved NDA/ANDA: FDA analysis found the product to contain undeclared sibutramine.
- Published
- January 31, 2018
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Earth's Care Eczema Lotion (2% Colloidal Oatmeal) Skin Protectant with Aloe and Almond Oil, 8 fl. oz. (237 mL) HPDE bottle, Distributed by: Earth's Care Natural Products, Inc. Long Beach, California 90805, NDC 24286-1569-08, UPC 85730700307.
by DLC Laboratories, Inc
- Reason
- Microbial Contamination of Non-Sterile Products.
- Published
- January 31, 2018
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Ibuprofen Tablets, USP 800 mg, 6 x 1900 Tablets bulk packed in double polybag shipper packs for further packaging, Rx only, Manufactured by: Marksans Pharma Ltd., Plot No. L-82, L-83, Verna Indl. Estate, Verna, Goa - 403 722, India, NDC 25000-123-27.
by Marksans Pharma Inc.
- Reason
- CGMP Deviations: Various strengths of ibuprofen tablets/caplets are being recalled due to complaints of odor related to CGMP deficiencies.
- Published
- January 31, 2018
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Ibuprofen Tablets, USP 400 mg, 6 x 3500 Tablets bulk packed in double polybag shipper packs for further packaging, Rx only, Manufactured by: Marksans Pharma Ltd., Plot No. L-82, L-83, Verna Indl. Estate, Verna, Goa - 403 722, India, NDC 25000-121-29.
by Marksans Pharma Inc.
- Reason
- CGMP Deviations: Various strengths of ibuprofen tablets/caplets are being recalled due to complaints of odor related to CGMP deficiencies.
- Published
- January 31, 2018
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Ibuprofen Tablets, USP 200 mg, 6 x 6500 Tablets bulk packed in double polybag shipper packs for further packaging, Rx only, Manufactured by: Marksans Pharma Ltd., Plot No. L-82, L-83, Verna Indl. Estate, Verna, Goa - 403 722, India, NDC 25000-114-30.
by Marksans Pharma Inc.
- Reason
- CGMP Deviations: Various strengths of ibuprofen tablets/caplets are being recalled due to complaints of odor related to CGMP deficiencies.
- Published
- January 31, 2018
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Ibuprofen Tablets, USP 200 mg, 6 x 6500 Tablets bulk packed in double polybag shipper packs for further packaging, Rx only, Manufactured by: Marksans Pharma Ltd., Plot No. L-82, L-83, Verna Indl. Estate, Verna, Goa - 403 722, India, NDC 25000-136-20.
by Marksans Pharma Inc.
- Reason
- CGMP Deviations: Various strengths of ibuprofen tablets/caplets are being recalled due to complaints of odor related to CGMP deficiencies.
- Published
- January 31, 2018
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Ibuprofen Tablets, USP 200 mg, 6 x 6500 Caplets (Capsule-Shaped Tablets) bulk packed in double polybag shipper packs for further packaging, Rx only, Manufactured by: Marksans Pharma Ltd., Plot No. L-82, L-83, Verna Indl. Estate, Verna, Goa - 403 722, India, NDC 25000-117-30.
by Marksans Pharma Inc.
- Reason
- CGMP Deviations: Various strengths of ibuprofen tablets/caplets are being recalled due to complaints of odor related to CGMP deficiencies.
- Published
- January 31, 2018
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Pravastatin Sodium Tablets, USP, 20 mg, 30-count bottles, packaged in 12 x 30 tablets for individual patient dispensing per pharmacy dispenser carton, Rx only, Packaged for: International Laboratories, LLC. St. Petersburg, FL 33710, NDC 54458-926-16.
by International Laboratories, Inc.
- Reason
- Presence of Foreign Tablets/Capsules: bottles could contain both pravastatin sodium 10 mg and 20 mg tablets in the same bottle.
- Published
- January 31, 2018
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Pravastatin Sodium Tablets, USP, 10 mg, 30-count bottles, packaged in 12 x 30 tablets for individual patient dispensing per pharmacy dispenser cartons, Rx only, Packaged for: International Laboratories, LLC. St. Petersburg, FL 33710, NDC 54458-927-16.
by International Laboratories, Inc.
- Reason
- Presence of Foreign Tablets/Capsules: bottles could contain both pravastatin sodium 10 mg and 20 mg tablets in the same bottle.
- Published
- January 31, 2018
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Dry to Normal Skin Starter Kit, Trousse debutante pour peau seche a normale. Kit includes: (Vegetable Cleanser (60 ml / 2 oz), Night Cream (15 g / 0.5 oz), Day Cream SPF15 {Octinoxate 7%, Avobenzone 2% and Oxybenzone 5%} (15 g / 0.5 oz), Eye Cream (6 g / 0.21 oz).Made in Canada, Kamins Dermatologics Inc. Montreal, Quebec H9R 2Y6. Distributed by Kamins Dermatologics (USA) Inc. 99 Hudson, New York, NY, USA. UPC code 6 06354 61322 4
by Odan Laboratories Ltd
- Reason
- Failed Stability Specifications:stability failure at 12 months, long term RT conditions.
- Published
- January 31, 2018
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Day Cream SPF15 Cr¿me de jour FPS 15, { Avobenzone 2%, Octinoxate 7%, Oxybenzone 5%} 15 ml / 0.5 fl. oz jar. Made in Canada, Kamins Dermatologics Inc. Montreal, Quebec H9R 2Y6. Distributed by Kamins Dermatologics Montreal, Quebec H9R 2Y6 Made in Fabrique au Canada. UPC code 6 26354 10955 0
by Odan Laboratories Ltd
- Reason
- Failed Stability Specifications:stability failure at 12 months, long term RT conditions.
- Published
- January 31, 2018
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
bupPROPion HCL Extended-Release Tablets, USP (XL) 300 mg, 500-count bottle, Rx only, Mylan Pharmaceuticals Inc. Morgantown, WV 26505 U.S.A. NDC: 0378-2009-05
by Mylan Pharmaceuticals Inc.
- Reason
- Failed Impurities/Degradation Specifications: Mylan Pharmaceuticals Inc. is conducting a voluntary recall due to related out of specification compound results obtained during routine stability testing.
- Published
- January 31, 2018
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
DOXOrubicin Hydrochloride Liposome Injection, 20 mg/10 ml (2 mg/mL), 10 mL Single Use Vial, Distributed by: Sun Pharmaceutical Industries , Inc. Cranbury, NJ 08512. Manufactured by: Sun Pharmaceutical Ind. Ltd. Halol-Baroda Highway. Halol-389 350, Gujarat, India. NDC 47335-049-40
by Sun Pharmaceutical Industries, Inc.
- Reason
- Lack Of Assurance Of Sterility
- Published
- January 31, 2018
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Ibuprofen Tablets, USP 600 mg, 6 x 2500 Tablets bulk packed in double polybag shipper packs for further packaging, Rx only, Manufactured by: Marksans Pharma Ltd., Plot No. L-82, L-83, Verna Indl. Estate, Verna, Goa - 403 722, India, NDC 25000-122-28.
by Marksans Pharma Inc.
- Reason
- CGMP Deviations: Various strengths of ibuprofen tablets/caplets are being recalled due to complaints of odor related to CGMP deficiencies.
- Published
- January 31, 2018
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Divalproex Sodium Delayed Release Tablets USP, 500 mg, 100-count bottle, RX Only, Manufactured by: Unichem Laboratories Ltd. Ind. Area, Meerut Road, Ghaziabad-201 003, India. Marketed By: Unichem Pharmaceuticals (USA), Inc. Hasbrouck Heights, NJ 07604. NDC 29300-140-01
by UNICHEM PHARMACEUTICALS USA INC
- Reason
- Cross Contamination With Other Products: metronidazole powder was found in one bottle of Divalproex Sodium.
- Published
- January 24, 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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