FDA Recall
🇺🇸 United States
Terminated
Historical recordClass III
Infiniti Creations, LLC
- Product
- Supervision Weightloss. 2oz HCG Drops. Amber Glass
- Reason
- The firm announced a voluntary recall of various dietary supplement products due to misbranding and some products may contain undeclared HCG.
- Published
- November 30, 2016
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass III
Infiniti Creations, LLC
- Product
- HCG Plus. 2oz HCG Drops. Blue Glass
- Reason
- The firm announced a voluntary recall of various dietary supplement products due to misbranding and some products may contain undeclared HCG.
- Published
- November 30, 2016
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
Zeasorb AF (miconazole nitrate), 2%, cures most athlete's foot, Net wt. 2.5 OZ (71 g), Manufactured for: Steifel Laboratories, Inc., Research Triangle Park, NC 27709, UPC 0 73462 15065 1; NDC 0145-1506-01
by GSK Consumer Healthcare
- Reason
- Labeling Not Elsewhere Classified: front labels have the incorrect NDC or 0145-1506-01 instead of the correct NDC of 0145-1506-05 and some back labels have the incorrect indication stating "use for the cure of most jock itch" rather than "use for the cure of most athlete's foot".
- Published
- November 23, 2016
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
L-Cysteine Hydrochloride Injection, USP, 50 mg/mL, 50 mL Pharmacy Bulk Package Vials (NDC 66758-005-01), packaged in 5 x 50 mL Vials per carton(NDC 66758-005-02), Rx only, Manufactured for: Sandoz, Inc., Princeton, NJ.
by Sandoz Inc
- Reason
- Lack of Assurance of Sterility: a recent FDA inspection at the manufacturing firm raised concerns that the product sterility may be compromised.
- Published
- November 23, 2016
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
L-Cysteine Hydrochloride Injection, USP, 0.5 g/10 mL (50 mg/mL), 10 mL Single Dose Vial (NDC 66758-004-01), packaged in 10 x 10mL Vials per carton (NDC 66758-004-02), Rx only, Manufactured for: Sandoz Inc., Princeton, NJ 08540.
by Sandoz Inc
- Reason
- Lack of Assurance of Sterility: a recent FDA inspection at the manufacturing firm raised concerns that the product sterility may be compromised.
- Published
- November 23, 2016
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
FIRST Omeprazole 2mg/mL in FIRST PPI Suspension Compounding Kit , 3 OZ, Rx only, Manufactured for CutisPharma Wilmington, MA, NDC# 65628-070-03
by CutisPharma, Inc.
- Reason
- Labeling: Label error on declared strength. Package Insert -Error in the Description section of the package insert refers to the strength as 3mg per mL; however it should state 2mg per mL
- Published
- November 23, 2016
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
FIRST Omeprazole 2mg/mL in FIRST PPI Suspension Compounding Kit , 5 oz., Rx only, Manufactured for CutisPharma Wilmington, MA, NDC# 65628-070-05
by CutisPharma, Inc.
- Reason
- Labeling: Label error on declared strength. Package Insert -Error in the Description section of the package insert refers to the strength as 3mg per mL; however it should state 2mg per mL
- Published
- November 23, 2016
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
Bupropion Hydrochloride Extended-Release Tablets, USP (XL), 300 mg, a) 90-count bottle (NDC 68001-264-05), b) 500-count bottle (NDC 68001-264-03) , Rx only, Manufactured by: Cadila Healthcare Limited, Ahmedabad, India For BluePoint Laboratories
by Amerisource Health Services
- Reason
- Failed Dissolution Specifications: The firm was notified that there was a dissolution out of specification result on the 6 month stability samples.
- Published
- November 23, 2016
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
Clonazepam Tablets, USP, 1.0 mg, packaged in a 100- count unit dose box of 10 x 10 blister cards, Rx only, Manufactured by Mylan Pharmaceuticals Inc, Morgantown, WV, 26505, NDC 51079-882-20
by Mylan Institutional, Inc. (d.b.a. UDL Laboratories)
- Reason
- Failed Impurities/Degradation Specifications: out of specification result for Clonazepam Related Compound (RC) A (a known impurity) at 16 month timepoint.
- Published
- November 16, 2016
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
Clonazepam Tablets, USP, 0.5 mg, packaged in a)100- count unit dose box of 10 x 10 blister cards (NDC 51079-881-20) and b) 300-count unit dose box of 10 x 30 punch cards (NDC 51079-881-56), Rx only, Manufactured by Mylan Pharmaceuticals Inc, Morgantown, WV, 26505
by Mylan Institutional, Inc. (d.b.a. UDL Laboratories)
- Reason
- Failed Impurities/Degradation Specifications: out of specification result for Clonazepam Related Compound (RC) A (a known impurity) at 15 month timepoint.
- Published
- November 16, 2016
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
Kamedis BIO-HERBAL DANDRUFF CARE THERAPEUTIC 2-STEP DANDRUFF CARE SYSTEM - Kamedis Bio-Herbal Dandruff Care 0.1% PYRITHIONE ZINC, STEP 1 PRE-TREAT Concentrated Botanical Scalp Lotion (0.1% Pyrithione Zinc) 4.20 FL OZ (125mL) (NDC 51672-2126-0) and STEP 2 CLEANSE Concentrated Botanical Dandruff Shampoo (1.0% Pyrithione Zinc)(0.6.80 FL OZ (200 mL) (NDC 51672-2125-5), Distributed by: Taro Pharmaceuticals U.S.A, Inc. Hawthorne, NY 10532. NDC
by Taro Pharmaceuticals U.S.A., Inc.
- Reason
- Subpotent Drug: Out of Specification assay values on stability for the active ingredient, zinc pyrithione.
- Published
- November 16, 2016
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Brownwood Farms
- Product
- Brownwood Farms Michigan Cherry Preserves 12oz glass bottle…
- Reason
- Products contain milk not declared on the label.
- Published
- November 16, 2016
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Brownwood Farms
- Product
- Brownwood Farms Strawberry Preserves 12oz glass bottles and…
- Reason
- Products contain milk not declared on the label.
- Published
- November 16, 2016
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Brownwood Farms
- Product
- Brownwood Farms America's Original Cherry Butter 12oz and…
- Reason
- Products contain milk not declared on the label.
- Published
- November 16, 2016
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Brownwood Farms
- Product
- Brownwood Farms Jalapeno Cherry Butter 12oz and 20oz glass…
- Reason
- Products contain milk not declared on the label.
- Published
- November 16, 2016
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Brownwood Farms
- Product
- Brownwood Farms Pear & Cinnamon Preserves 10oz glass bottle…
- Reason
- Products contain milk not declared on the label.
- Published
- November 16, 2016
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Brownwood Farms
- Product
- Brownwood Farms Cherry Raspberry Preserves 12oz glass bottl…
- Reason
- Products contain milk not declared on the label.
- Published
- November 16, 2016
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
The Hershey Company
- Product
- SOFiT Protein Plus Pumpkin Seeds Sesame Garlic, Seeds covere…
- Reason
- The Hershey Company has issued a voluntary recall of three products sold under the SoFit brand after a supplier who provides sunflower seeds for the products expanded its recall on June 1. Products have the potential to be contaminated with Listeria monocytogenes.
- Published
- November 16, 2016
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
The Hershey Company
- Product
- SOFiT Protein Plus Almonds Jalapeno Garlic, whole almonds co…
- Reason
- The Hershey Company has issued a voluntary recall of three products sold under the SoFit brand after a supplier who provides sunflower seeds for the products expanded its recall on June 1. Products have the potential to be contaminated with Listeria monocytogenes.
- Published
- November 16, 2016
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
The Hershey Company
- Product
- SOFiT Protein Plus Sunflower Seeds Sea Salt; Seeds covered b…
- Reason
- The Hershey Company has issued a voluntary recall of three products sold under the SoFit brand after a supplier who provides sunflower seeds for the products expanded its recall on June 1. Products have the potential to be contaminated with Listeria monocytogenes.
- Published
- November 16, 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.
Read the full medical disclaimer.