FDA Recall
Terminated
Historical recordClass III
CLENZIderm M.D. Acne Treatment System, kit has 3 bottles a) Therapeutic Lotion (benzoyl peroxide 5% Acne Treatment) 47mL bottle, b) Daily Care Foaming Cleanser (Salicylic Acid 2% Acne Treatment) 118 mL bottle, c) Salicylic Acid 2% Acne Treatment 148mL, Valeant Pharmaceuticals North America LLC Distributed by OMP, Inc Long Beach, CA 90806 Made in USA, Product SKU 301876103018, NDC 0187-6103-01
by Valeant Pharmaceuticals North America LLC
- Reason
- Discoloration.
- Published
- April 26, 2017
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
CLENZIderm M.D. Pore Therapy Salicylic Acid 2% Acne Treatment 5 fl. oz. (148 mL), Valeant Pharmaceuticals North America LLC Distributed by OMP, Inc Long Beach, CA 90806 Made in USA. Product SKU 301876102042, NDC 0187-6102-04
by Valeant Pharmaceuticals North America LLC
- Reason
- Discoloration.
- Published
- April 26, 2017
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
The French's Food Company, LLC SUBS Reckitt Benckiser
- Product
- French's Crispy Jalapenos Net Wt. 5 oz. (141.7g), UPC 0 4150…
- Reason
- Product may contain foreign objects: rocks and metal fragments.
- Published
- April 26, 2017
- Distribution
- Product was distributed to CA, KS, MN, M…
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Dawn Food Products Inc.
- Product
- SHEILA G'S EGGLESS BROWNIE BRITTLE MIX Item 02403038 50 lb…
- Reason
- Products may contain Salmonella. These products contain ingredients recalled by Valley Milk Products for potential Salmonella contamination.
- Published
- April 26, 2017
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
Dawn Food Products Inc.
- Product
- R&H CHOCOLATE Speedy Creme Instant Pudding and Pie Filling…
- Reason
- Products may contain Salmonella. These products contain ingredients recalled by Valley Milk Products for potential Salmonella contamination.
- Published
- April 26, 2017
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
Dawn Food Products Inc.
- Product
- R&H Speedy Creme Vanilla Filling Mix Item 01148908 25 pou…
- Reason
- Products may contain Salmonella. These products contain ingredients recalled by Valley Milk Products for potential Salmonella contamination.
- Published
- April 26, 2017
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
Dawn Food Products Inc.
- Product
- R&H VANILLA Speedy Creme Instant Pudding and Pie Filling Mi…
- Reason
- Products may contain Salmonella. These products contain ingredients recalled by Valley Milk Products for potential Salmonella contamination.
- Published
- April 26, 2017
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
Dawn Food Products Inc.
- Product
- QUIK 'N CREAMY VANILLA POWDERED FILLING Item number 000141…
- Reason
- Products may contain Salmonella. These products contain ingredients recalled by Valley Milk Products for potential Salmonella contamination.
- Published
- April 26, 2017
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
BuPROPion Hydrochloride Extended-release Tablets, USP (SR), 200 mg, packaged in a) 60-count bottles (NDC 59746-317-60) and b) 100-count bottles (NDC 59746-317-01), Rx only, Manufactured by: Julibant Life Sciences Ltd., Roorkee-247661, India; Marketed by: Jubilant Cadista Pharmaceuticals Inc., Salisbury, MD 21801, USA.
by Jubilant Cadista Pharmaceuticals, Inc.
- Reason
- Failed Impurities/Degradation Specifications: high out of specification results for one of the known degradation products, m-chlorobenzoic acid.
- Published
- April 19, 2017
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
BuPROPion Hydrochloride Extended-release Tablets, USP (SR), 150 mg, packaged in a) 60-count bottles (NDC 59746-316-60) and b) 100-count bottles (NDC 59746-316-01), Rx only, Manufactured by: Julibant Life Sciences Ltd., Roorkee-247661, India; Marketed by: Jubilant Cadista Pharmaceuticals Inc., Salisbury, MD 21801, USA.
by Jubilant Cadista Pharmaceuticals, Inc.
- Reason
- Failed Impurities/Degradation Specifications: high out of specification results for one of the known degradation products, m-chlorobenzoic acid.
- Published
- April 19, 2017
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
BuPROPion Hydrochloride Extended-release Tablets, USP (SR), 100 mg, packaged in a) 60-count bottles (NDC 59746-315-60) and b) 100-count bottles (NDC 59746-315-01), Rx only, Manufactured by: Julibant Life Sciences Ltd., Roorkee-247661, India; Marketed by: Jubilant Cadista Pharmaceuticals Inc., Salisbury, MD 21801, USA.
by Jubilant Cadista Pharmaceuticals, Inc.
- Reason
- Failed Impurities/Degradation Specifications: high out of specification results for one of the known degradation products, m-chlorobenzoic acid.
- Published
- April 19, 2017
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
hydrALAZINE HYDROCHLORIDE INJECTION, USP, 20 mg/mL, 1 mL Single Dose Vial, packaged in 25 Vials per carton, Rx only, APP Fresenius Kabi USA, LLC, Lake Surich, IL 60047, NDC 63323-614-01, Distributed by McKesson Medical-Surgical, Inc.
by Mckesson Medical Surgical
- Reason
- Temperature Abuse: Certain pieces of these lots distributed by McKesson Medical Surgical Inc. were inadvertently stored refrigerated rather than the labeled room temperature recommendation.
- Published
- April 19, 2017
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
Lumigan (bimatoprost ophthalmic solution) 0.01%, 7.5 mL bottle, Rx only, Allergan Irvine, CA 92612, NDC 0023-3205-08.
by Allergan Sales, LLC
- Reason
- Failed Impurities/Degradation Specifications
- Published
- April 19, 2017
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
ESTRADIOL, USP Bulk (Hemihydrate), in a) 25 g (NDC 38779-2261-04) and b) 100 g (NDC 38779-2261-05) bottles, Packed by MEDISCA INC. PLATTSBURGH, NY Product Code 2261
by Medisca, Inc.
- Reason
- cGMP Deviations; manufacturer initiated recall of API product after deficiencies noted during a recent FDA inspection
- Published
- April 19, 2017
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
ESTRADIOL, USP (Hemihydrate)(Micronized), in a) 100 mg (NDC 38779-0869-07), b) 1 g (NDC 38779-0869-06), c) 5 g (NDC 38779-0869-03), d) 10 g (NDC 38779-0869-01), e) 25 g (NDC 38779-0869-04), f) 100 g (NDC 38779-0869-05) , g) 500 g (NDC 38779-0869-08), h) 1 Kg (NDC 38779-0869-09) bottles, Packed by MEDISCA INC. PLATTSBURGH, NY 12901; Product Code 0869
by Medisca, Inc.
- Reason
- cGMP Deviations; manufacturer initiated recall of API product after deficiencies noted during a recent FDA inspection
- Published
- April 19, 2017
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
ESTRONE, USP Bulk, in a) 100 mgs (NDC 38779-0891-05), b) 1 gram (NDC 38779-0891-06), c) 5 grams (NDC 38779-0891-03), d) 25 grams (NDC 38779-0891-04), and e) 100 grams (NDC 38779-0891-09) Bottles, Packed by MEDISCA INC. PLATTSBURGH, NY 12901; Product Code 0891
by Medisca, Inc.
- Reason
- cGMP Deviations; manufacturer initiated recall of API product after deficiencies noted during a recent FDA inspection
- Published
- April 19, 2017
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
ESTRIOL, USP (Micronized) Bulk, in a) 5 grams (NDC 38779-0732-03), b) 25 grams (NDC 38779-0732-04) , c) 100 grams (NDC 38779-0732-05), and d) 1 Kg (NDC 38779-0732-09) bottles, Packed by MEDISCA, INC. PLATTSBURGH, NY 12901; Product Code 0732
by Medisca, Inc.
- Reason
- cGMP Deviations; manufacturer initiated recall of API product after deficiencies noted during a recent FDA inspection
- Published
- April 19, 2017
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
Historical recordClass II
Double Hyaluronic 1000, 'AN OUNCE OF GOLD' Volumizing Day Cream, Broad Spectrum SPF 30+, (Octinoxate 7.725%, Oxybenzone 6.18%, Octisalate 5.15%, Avobenzone 3.09%), Net Wt. 1.8 oz. (51 g) jar, Distributed by Signature Club A, Ltd, Tampa, FL 33609.
by Signature Club A Ltd
- Reason
- Microbial Contamination of Non-Sterile Products: odor complaint of product due to microbial contamination.
- Published
- April 19, 2017
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
LATANOPROST OPHTHALMIC SOLUTION, 0.005%, 125 ug/2.5 mL, packaged in 2.5 mL bottle, Rx only, Manufactured for: Akorn, Inc., Lake Forest, IL 60045, NDC 17478-625-12
by Akorn, Inc.
- Reason
- Lack of assurance of sterility: product was found to be empty, under-filled, or leaking.
- Published
- April 19, 2017
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
Fluocinolone Acetonide Topical Solution USP 0.01% For Topical Use Only, Not for Ophthalmic Use, 60 mL bottle, Rx Only, Manufactured for Gavis Pharmaceuticals, LLC, Somerset NJ 08873, Manufactured by Novel Laboratories, Inc. Somerset, NJ 08873, NDC 43386-069-60
by Novel Laboratories, Inc.
- Reason
- Chemical Contamination
- Published
- April 19, 2017
- 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.
Read the full medical disclaimer.