FDA Recall
Terminated
Historical recordClass II
Methylphenidate Hydrochloride, Extended-release Tablets, USP, 36mg, 100-count Bottle, Rx Only, Manufactured for: Trigen Laboratories, LLC, Alpharetta, GA 30005, NDC 13811-708-10
by Trigen Laboratories
- Reason
- Failed dissolution specifications: this product is being recalled due to this batch not meeting dissolution specifications.
- Published
- July 10, 2024
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
Historical recordClass II
Little Moon Essentials, Clear Breeze Plus, Hand Sanitizer (Alcohol 65% v/v) Packaged as a) 2 FL OZ (60ML) spray bottle, UPC Code 6 73673 88797 3, NDC 70722-319-02; b) 4 FL OZ (118ML) spray bottle, UPC Code 6 73673 88798 0, NDC 70722-319-04; Little Moon Essentials LLC Dania Beach, Fl 33004
by Little Moon Essentials LLC
- Reason
- CGMP deviations
- Published
- July 10, 2024
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
Historical recordClass II
Little Moon Essentials, Asana Kisser, (Camphor 1.35%, Menthol 2.86%), Packaged as a) 0.5 OZ (14G) metal tin, UPC Code 6 73673 88227 5, NDC 70722-216-05; b) 3 OZ (85-05G) metal tin UPC Code 6 73673 88216 9, NDC 70722-216-03; Little Moon Essentials LLC Dania Beach, Fl 33004
by Little Moon Essentials LLC
- Reason
- CGMP deviations
- Published
- July 10, 2024
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
Historical recordClass II
Little Moon Essentials, Ass Kisser, Packaged as a) 0.5 OZ (14G) metal tin, UPC Code 6 73673 88228 2, NDC 70722-208-05; b) 3 OZ (85.05G) metal tin, UPC Code 6 73673 88208 4, NDC 70722-208-03; Little Moon Essentials LLC Dania Beach, Fl 33004
by Little Moon Essentials LLC
- Reason
- CGMP deviations
- Published
- July 10, 2024
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
Historical recordClass II
Little Moon Essentials, Vital Vapor Balm, (Camphor 0.6%, Menthol 5.2%) Packaged as a) 0.5OZ (14G) metal tin, UPC Code 6 73673 88231 2, NDC 70722-229-05) b) 2OZ (57G) glass jar, UPC Code 6 73673 88220 6, NDC 70722-229-02; c) 4OZ (113G) glass jar, UPC Code 6 73673 88218 3, NDC 70722-229-04; Little Moon Essentials LLC Dania Beach, Fl 33004
by Little Moon Essentials LLC
- Reason
- CGMP deviations
- Published
- July 10, 2024
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
Historical recordClass II
Little Moon Essentials, Dream Cream (Camphor 0.45%, Menthol 5%), Packaged as a) 2OZ (57G) glass jar, UPC Code 6 73673 88214 5, NDC 70722-232-02; b) 4OZ (113G) glass jar, UPC Code 6 73673 88804 8, NDC 70722-232-04; Little Moon Essentials LLC Dania Beach, Fl 33004
by Little Moon Essentials LLC
- Reason
- CGMP deviations
- Published
- July 10, 2024
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
Historical recordClass II
Little Moon Essentials, Aching Head Rub (Camphor 3.09%, Menthol 2.55%) , a) 0.5OZ (14G), metal tin, UPC Code 67367388226 8, NDC 70722-203-05; b)1OZ (28G) glass jar, UPC Code 6 73673 88203 9, NDC 70722-203-01; Little Moon Essentials LLC Dania Beach, Fl 33004
by Little Moon Essentials LLC
- Reason
- CGMP deviations
- Published
- July 10, 2024
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
Historical recordClass II
Little Moon Essentials, Crampy Belly Rub (Camphor 1.1%), Packaged as a) 4 FL OZ (118ML) glass jar, UPC Code 6 73673 88260 2, NDC 70722-260-04; b) 2 FL OZ (59ML) glass jar, UPC Code 6 73673 88204 6, NDC 70722-260-02, Little Moon Essentials LLC Dania Beach, Fl 33004
by Little Moon Essentials LLC
- Reason
- CGMP deviations
- Published
- July 10, 2024
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
Historical recordClass II
Little Moon Essentials, Magical Muscle Oil, (Camphor 1.95%, Menthol 3.75%) packaged as: a) 2 FL OZ (59ML) glass jar, UPC Code 6 73673 88202 2, NDC 70722-246-02; b) 4 FL OZ (118ML) jar, UPC Code 6 73673 88233 6, NDC 70722-246-04; Little Moon Essentials LLC Dania Beach, Fl 33004
by Little Moon Essentials LLC
- Reason
- CGMP deviations
- Published
- July 10, 2024
- Distribution
- Nationwide
View recall →
FDA Recall
Completed
Historical recordClass II
Budesonide, USP (Micronized), 500 mg, White to off-white odorless, crystalline powder, Medisca Inc., Plattsburgh, NY, 12901, USA, NDC: 38779-3097-00.
by Medisca Inc.
- Reason
- CGMP Deviations and Presence of Particulate Matter: Glass
- Published
- July 10, 2024
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Breadbox Co.
- Product
- Breadman Brioche products in plastic bags: Brioche Toast, 2…
- Reason
- Undeclared Yellow No. 5
- Published
- July 10, 2024
- Distribution
- No foreign or government consignees. The…
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Breadbox Co.
- Product
- Breadman Raisin Bread, plastic bag, 16oz
- Reason
- Undeclared milk allergen and undeclared Yellow No. 5
- Published
- July 10, 2024
- Distribution
- No foreign or government consignees. The…
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Breadbox Co.
- Product
- Breadman Jalapeno Cheese Bagels, plastic bag, 16oz
- Reason
- Undeclared milk allergen
- Published
- July 10, 2024
- Distribution
- No foreign or government consignees. The…
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Grato Holdings, Inc.
- Product
- BioActive Nutritional MINAPLEX, Botanical Herbal Supplement;…
- Reason
- Potential microbial contamination (yeast and/or mold).
- Published
- July 10, 2024
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Grato Holdings, Inc.
- Product
- Energique Mineral Magic Dietary Supplement, 2 fl. oz (59 ml)…
- Reason
- Potential microbial contamination (yeast and/or mold).
- Published
- July 10, 2024
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Lidl US TRADING
- Product
- Italiamo brand Melanzane alla Parmigiana pregratinate (Eggpl…
- Reason
- Undeclared wheat and milk (foreign language labeling)
- Published
- July 10, 2024
- Distribution
- Distributed to distribution centers and…
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
Penn Herb Company, Ltd.
- Product
- Nature's Wonderland brand Thyroid Formula 60 Veg Capsules UP…
- Reason
- Potential Salmonella contamination
- Published
- July 10, 2024
- Distribution
- Distributed to customers in PA, CA, IL,…
View recall →
FDA Recall
Ongoing
Historical recordClass III
SinuFrin Decongestant (oxymetazoline HCl) Nasal Solution Nasal Decongestant, Decongestant Relief for up to 12 Hours, 12 Hour Relief, 0.5 fl oz (15 ml) bottle, Manufactured by NeilMed Pharmaceuticals Inc, 602 Aviation Blvd, Santa Rosa, CA 95403 877-477-8633; NDC 13709-325-01; UPC 7 05928 09001 9.
by Neilmed Pharmaceuticals Inc
- Reason
- Sub-potent Drug
- Published
- July 3, 2024
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Duloxetine Delayed-Release Capsules, USP, 30mg, Rx Only, a) 30 capsules bottles, NDC 60429-165-30; b) 90 capsules bottles, NDC 60429-165-90, Mfr. by: Towa Pharmaceutical Europe, S.L. Martorelles, (Barcelona), Spain, Packaged by GSMS, Incorporated, Camarillo, CA 93012.
by Golden State Medical Supply Inc.
- Reason
- CGMP Deviations: Presence of Nitrosamine Drug Substance Related Impurity (NDSRI), N-nitroso-duloxetine, above the proposed interim limit.
- Published
- July 3, 2024
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
Historical recordClass II
Zilretta (triamcinolone acetonide extended-release injectable suspension), 32 mg per vial, Rx only, Manufactured for: Pacira Pharmaceuticals Inc., San Diego, CA 92121, NDC 65250-003-01 (carton) NDC 65250-001-01 (vial) with Diluent 5 mL Sterile single-use vial, Rx Only, Mfd. for: Pacira Pharmaceuticals, Inc. NDC 65250-002-01
by PACIRA PHARMACEUTICALS INC
- Reason
- Failed Dissolution Specifications - did not meet the acceptance criteria for IVR Level 3 testing at 9 months 2-8¿C followed by 6 weeks at 25¿C
- Published
- July 3, 2024
- 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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