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 →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
Professional Botanicals
- Product
- Professional Botanicals MealPlex (756 grams) and Veo Natural…
- Reason
- Professional Botanicals announces a voluntary field action for MealPlex and Pearl due to undeclared milk allergen.
- Published
- November 16, 2016
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Rich Products Corp
- Product
- New York Style Chocolate Iced ¿clairs under the following la…
- Reason
- Products were recalled due to the potential presence of plastic foreign material.
- Published
- November 16, 2016
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Truco Enterprises, Inc
- Product
- On the Border Blue Corn Tortilla Chips 7.25 oz. and 10 oz. p…
- Reason
- Possible metal fragments in corn flour.
- Published
- November 16, 2016
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Truco Enterprises, Inc
- Product
- On the Border Cafe Style Tortilla Chips 18 oz. and 28 oz. pa…
- Reason
- Possible metal fragments in corn flour.
- Published
- November 16, 2016
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass III
Tasty Toppings Inc
- Product
- Dorothy Lynch Homestyle 8 oz., 16 oz., and 32 oz. bottles (1…
- Reason
- The firm issued a press release on May 6, 2016, which encouraged consumers with affected bottles to return the product to the store for a refund. The recall will extend through the wholesale and retail distribution chain via scripted phone notification. The firm has informed distributors/retails to remove the product from shelves and track by using the best by date and sku. Products should be destroyed. The information has been posted on the firm website.
- Published
- November 16, 2016
- Distribution
- Coverage is predominately the Midwest, s…
View recall →
FDA Recall
Terminated
Historical recordClass II
Succinylcholine Chloride, 20 mg per mL, 200 mg per 10 mL, 10 mL vials, Rx only, PharMEDium Services, LLC, Memphis, TN, NDC 61553-0364-65.
by PharMEDium Services, LLC
- Reason
- Lack of Assurance of Sterility: A portion of the batch quantity was compounded outside of the firm's process media validation.
- Published
- November 9, 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.
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