FDA Recall
Terminated
Historical recordClass I
Dr. King's Natural Medicine Homeopathic Regional Allergies Great Lakes U.S., 2 fl. oz. (59 mL), King Bio, Inc., 3 Westside Dr. Asheville, NC 28806, UPC 357955519027, NDC 57955-8195-2
by King Bio Inc.
- Reason
- Microbial contamination
- Published
- March 20, 2019
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass I
Dr. King's Natural Medicine Homeopathic Regional Allergies Southern U.S., 2 fl. oz. (59 mL), King Bio, Inc., 3 Westside Dr. Asheville, NC 28806, UPC 357955518426, NDC 57955-0760-2
by King Bio Inc.
- Reason
- Microbial contamination
- Published
- March 20, 2019
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass I
Dr. King's Natural Medicine Homeopathic Regional Allergies Pacific U.S. 2 fl. oz. (59 mL), King Bio, Inc., 3 Westside Dr. Asheville, NC 28806, UPC 357955519324, NDC 57955-8198-2
by King Bio Inc.
- Reason
- Microbial contamination
- Published
- March 20, 2019
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass I
Dr. King's Natural Medicine Homeopathic Cold Sores & Herpes, 2 fl. oz. (59 mL), King Bio, Inc., 3 Westside Dr. Asheville, NC 28806, UPC 357955516521, NDC 57955-5165-2
by King Bio Inc.
- Reason
- Microbial contamination
- Published
- March 20, 2019
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Nature'S Path Foods Inc
- Product
- Nature's Path Organic Cinnamon Jungle Munch cereal. Net Wt.…
- Reason
- Gluten-free Cereals may contain undeclared gluten (wheat and barley).
- Published
- March 20, 2019
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Nature'S Path Foods Inc
- Product
- Nature's Path Organic Gorilla Munch Corn Puffs cereal. Net…
- Reason
- Gluten-free Cereals may contain undeclared gluten (wheat and barley).
- Published
- March 20, 2019
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Nature'S Path Foods Inc
- Product
- Nature's Path Organic Chocolate Choco Chimps Organic cereal.…
- Reason
- Gluten-free Cereals may contain undeclared gluten (wheat and barley).
- Published
- March 20, 2019
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Earthworks Health
- Product
- Diatomaceous Earth packaged in the following ways: 1) Per…
- Reason
- Product contains elevated levels of lead, arsenic, and chromium: potentially harmful metals.
- Published
- March 20, 2019
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Tamsulosin Hydrochloride Capsules, USP, 0.4 mg, 500-count bottles, Rx Only, Manufactured by: Alkem Laboratories Ltd., Mumbai - 400 013, INDIA; Distributed by Ascend Laboratories, LLC, Parsippany, NJ 07054, NDC 67877-450-05.
by Ascend Laboratories LLC
- Reason
- Failed Dissolution Specifications: High Out-of-Specification dissolution results were observed during stability testing.
- Published
- March 13, 2019
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
ATHLETICARE Anti-Bacterial Hand Soap AC 550 (triclosan), 0.25%, 4 litres/1.1 US Gallon bottles, packaged in 4 x 4 Litres/1.1 US gallons per case, Petra Hygienic Systems, Concord, ON L4K 4RS/ Reno, NV 89511, NDC 42326-550-01, UPC 0 65936 10335 5.
by Petra Hygienic Systems Int Ltd
- Reason
- Does Not Meet Monograph: product contains, triclosan, an ingredient that can no longer be contained in over-the-counter consumer antiseptic/antibacterial wash products.
- Published
- March 13, 2019
- Distribution
- Nationwide
View recall →
FDA Recall
Completed
Historical recordClass II
Drospirenone and Ethinyl Estradiol Tablets, USP, 3 mg/0.03 mg, 28 Tablets Blister, 1 Unit (NDC 60505-4183-1) packaged as 84 Tablets Blister, 3x1 Unit per carton (NDC 60505-4183-3), Rx Only, Manufactured for: Apotex Corp., Weston, FL 33326; Manufactured by: Oman Pharmaceutical Products Co. L.L.C., P.O. Box 1885, Postal Code 111, Seeb.
by Apotex Inc.
- Reason
- Contraceptive Tablets Out of Sequence: Missing or incorrect tablet placement.
- Published
- March 13, 2019
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass III
Twenty-First Century Healthcare, Inc
- Product
- Good Neighbor Pharmacy, D 2000 IU, Dietary Supplement, UPC:…
- Reason
- 21st Century HealthCare, Inc. is recalling Good Neighbor Pharmacy brand Co Q10 200mg 30ct capsules due the product being mislabeled and potentially containing Vit D 2000 IU.
- Published
- March 13, 2019
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass III
Twenty-First Century Healthcare, Inc
- Product
- Good Neighbor Pharmacy, Co Q10 200mg Capsule, Dietary Supple…
- Reason
- 21st Century HealthCare, Inc. is recalling Good Neighbor Pharmacy brand Co Q10 200mg 30ct capsules due the product being mislabeled and potentially containing Vit D 2000 IU.
- Published
- March 13, 2019
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Concord Foods, LLC
- Product
- Concord Fresh Success Mild Salsa Seasoning Mix, Packaged in…
- Reason
- Product contains undeclared allergen, milk.
- Published
- March 13, 2019
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Meijer
- Product
- Meijer Ultimate Chocolate Mint Chip Cookie Cookies in clea…
- Reason
- Undeclared soy
- Published
- March 13, 2019
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
World Waters, LLC dba WTRMLN WTR
- Product
- Watermelon, WTRMLNWTR Cold Pressured, 12fl oz, Watermelon Fl…
- Reason
- Cold Pressed Juice Watermelon WTRMLN WTR Original 12 packs due to the potential presence of soft plastic that may be loosely floating in some of the finished products.
- Published
- March 13, 2019
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
Moxifloxacin Ophthalmic Solution USP, 0.5%, 3 mL bottle, Rx only, Manufactured by: Lupin Limited, Pithampur (M.P.) 454 775, INDIA, NDC 68180-422-01.
by Lupin Pharmaceuticals Inc.
- Reason
- Failed Impurities/Degradation Specifications: Expansion of July 2018 and February 2019 recall due to high out-of-specification for impurities.
- Published
- March 6, 2019
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Threshold Enterprises Ltd
- Product
- Planetary Herbals Mullein Lung Complex; 1000 mg; 15 count,…
- Reason
- Recall of Mullein Lung Complex due to a labeling error which indicates the incorrect excipient profile (inactive ingredients).
- Published
- March 6, 2019
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
Clobetasol Propionate Emollient Cream 0.05%, a) 30 gram (NDC 50383-270-30) and b) 60 gram (NDC 50383-270-60) tubes, Rx only. Manufacturer: Akorn Inc. 369 Bayview Ave., Amityville, NY 117701.
by Akorn Inc
- Reason
- Failed Stability Specification; out of specification (OOS) results for a preservative at 9 month stability study.
- Published
- February 27, 2019
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
Mometasone Furoate Cream, 0.1%, 45 g tube, Rx Only, Manufactured by: G&W Laboratories, Inc. South Plainfield, NJ 07080, NDC 0713-0726-37
by ACP Nimble Buyer, Inc.
- Reason
- Labeling: Not Elsewhere Classified. Mometasone Furoate Cream has an NDC typographical error.
- Published
- February 27, 2019
- 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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