FDA Recall
TerminatedTerminated: February 27, 2020Historical recordClass II
FastStat Topical Hemostat Introductory Kit, 10% Ferric Sulfate 10%, Rx Only, 3-3cc preloaded syringes. CAO GROUP, INC, 4628 West Skyhawk Drive West Jordan, UT 84084. NDC 1406001003
by CAO Group, Inc.
- Reason
- cGMP violations noted during the firm's most recent inspection.
- Published
- December 19, 2018
- Distribution
- Nationwide
View recall →
FDA Recall
TerminatedTerminated: February 27, 2020Historical recordClass II
BeeGentle Honey Flavored Topical Anesthetic, Active ingredient Benzocaine 20%. Packaged in: a) Introductory Kit. Net Qty 3-3cc preloaded syringes. . NDC# 1406000203 UPC 8 72320 00074 5 b) Bulk Kit Net Qty 30mL, NDC# 1406000202, UPC 8 72320 00076 9. Manufactured by CAO (China) Medical Equipment Co. Ltd. for CAO Group, Inc. 4628 West Skyhawk Drive, West Jordan, UT 84084
by CAO Group, Inc.
- Reason
- cGMP violations noted during the firm's most recent inspection.
- Published
- December 19, 2018
- Distribution
- Nationwide
View recall →
FDA Recall
TerminatedTerminated: February 27, 2020Historical recordClass II
SHEER DesenZ Desensitizing Treatment, Rx Only, Potassium Nitrate 12mg per film. CAO GROUP, INC, 4628 West Skyhawk Drive West Jordan, UT 84084. UPC: 8 72320 00072 1 NDC 1406000304
by CAO Group, Inc.
- Reason
- cGMP violations noted during the firm's most recent inspection.
- Published
- December 19, 2018
- Distribution
- Nationwide
View recall →
FDA Recall
TerminatedTerminated: February 27, 2020Historical recordClass II
fas.TRACT Coagulative Hemostatic Gel, 10% Ferric Sulfate Kit, Rx Only, (3) 3cc Preloaded Syringes/ (50) Scrub Tips. Distributed by: Benco Dental, 295 Center Point Blvd., Pittston, PA 18640. NDC: 14060-01105
by CAO Group, Inc.
- Reason
- cGMP violations noted during the firm's most recent inspection.
- Published
- December 19, 2018
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
TerminatedTerminated: September 14, 2020Historical recordClass II
Feast Mode Blending & Filling
- Product
- Feast Mode Flavors Garlic Beer Seasoning, Nt. Wt. 5 oz, plas…
- Reason
- Feast Mode Garlic Beer Seasoning is mislabeled as "Gluten Free"
- Published
- December 19, 2018
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
TerminatedTerminated: June 7, 2019Historical recordClass II
4Patriots, LLC
- Product
- 4Patriots Chicken a la King CONTAINS: Wheat, Coconut NET W…
- Reason
- Milk not declared on product label.
- Published
- December 19, 2018
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
TerminatedTerminated: July 17, 2019Historical recordClass II
Schwan's Global Supply Chain, Inc.
- Product
- Schwan's Sea Salt Carmel Cashew Ice Cream (#206). Net Wt 56…
- Reason
- One date of production of Schwan's Sea Salt Caramel Cashew Ice Cream is being due to potential glass contamination.
- Published
- December 19, 2018
- Distribution
- Nationwide
View recall →
FDA Recall
TerminatedTerminated: May 1, 2023Historical recordClass I
SODIUM CHLORIDE INJECTION, USP, 0.9%, 20 mL Single Dose Vial, packaged in a 25-unit tray, Rx Only, APP Pharmaceuticals, LLC Schaumburg, IL 60173. NDC 63323-186-20, Product code 918620
by Fresenius Kabi USA, LLC
- Reason
- Labeling Not Elsewhere Classified: Fresenius Kabi is taking this action due to an incorrect statement on the product insert for product codes 918610 and 918620 indicating that the stoppers do not contain natural rubber latex. The tray label for these two product codes and the vial label for product code 918620 also incorrectly state that the stoppers do not contain latex. The above listed product codes and batches being recalled have stoppers containing natural rubber latex.
- Published
- December 12, 2018
- Distribution
- Nationwide
View recall →
FDA Recall
TerminatedTerminated: May 1, 2023Historical recordClass I
SODIUM CHLORIDE INJECTION, USP, 0.9%, 10 mL Single Dose Vial, packaged in a 25-unit tray, Rx Only, APP Pharmaceuticals, LLC Schaumburg, IL 60173. NDC 63323-186-10 Product code 918610
by Fresenius Kabi USA, LLC
- Reason
- Labeling Not Elsewhere Classified: Fresenius Kabi is taking this action due to an incorrect statement on the product insert for product codes 918610 and 918620 indicating that the stoppers do not contain natural rubber latex. The tray label for these two product codes and the vial label for product code 918620 also incorrectly state that the stoppers do not contain latex. The above listed product codes and batches being recalled have stoppers containing natural rubber latex.
- Published
- December 12, 2018
- Distribution
- Nationwide
View recall →
FDA Recall
TerminatedTerminated: February 1, 2022Historical recordClass III
Amlodipine and Olmesartan Medoxomil Tablets, 5 mg/40 mg, Rx only, 30-count bottle, Distributed by: Aurobindo Pharma USA, Inc. 279 Princeton-Hightstown Road East Windsor, NJ 0852 Made in India, NDC 65862-855-30
by Aurobindo Pharma USA Inc.
- Reason
- Discoloration: This product is being recalled due to a confirmed pharmacist report that tablets from this lot were a pink color instead of cream (peach).
- Published
- December 12, 2018
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
TerminatedTerminated: April 9, 2019Historical recordClass I
Agropur MSI Ingredients LLC
- Product
- Jay Robb Unflavored Egg White Protein, Net Weight 24 oz (1.5…
- Reason
- JayRobb Unflavored Egg White Protein Product is being recalled due to undeclared milk.
- Published
- December 12, 2018
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
TerminatedTerminated: February 11, 2019Historical recordClass II
First Source, LLC
- Product
- Chocolate and Nut Tray. The product comes in a four-quadrant…
- Reason
- Product contains undeclared pecans and cashews.
- Published
- December 12, 2018
- Distribution
- Multiple states
View recall →
FDA Recall
🇺🇸 United States
TerminatedTerminated: December 3, 2018Historical recordClass II
Rich Products Corp
- Product
- VANILLA WHIPPED ICING ARTIFICALLY FLAVORED Product Number: 0…
- Reason
- Possible contamination with cleaning chemicals.
- Published
- December 12, 2018
- Distribution
- Nationwide
View recall →
FDA Recall
TerminatedTerminated: August 9, 2022Historical recordClass III
Clindamycin Phosphate Topical Solution USP, 1% (10 mg/mL clindamycin), 60 pledget applicators per jar, Rx only. Manufactured by Ei LLC 2865 N. Cannon Blvd. Kannapolis, NC 18083. NDC# 61748-0201-60
by Akorn, Inc.
- Reason
- Failed Impurities/Degradation Specifications; out of specification results observed for other individual impurities
- Published
- December 5, 2018
- Distribution
- Nationwide
View recall →
FDA Recall
TerminatedTerminated: March 30, 2020Historical recordClass II
Quetiapine Tablets USP 400 mg, 100 tablet bottles, Rx Only, Manufactured by: Alkem Laboratories Ltd., Mumbai - 400 013, India. Distributed by: Ascend Laboratories, LLC Parsippany, NJ 07054 --- NDC 67877-248-01, UPC code: 3 67877-248-01 1
by Ascend Laboratories LLC
- Reason
- Presence of Foreign Substance; metal shard found in tablet
- Published
- December 5, 2018
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
TerminatedTerminated: October 8, 2019Historical recordClass I
Chukar Cherry Company
- Product
- Organic Ultra Dark Orange Chocolate Tart Cherries, Chukar Ch…
- Reason
- Product contains unintentional presence of milk and therefore milk was not listed on the label as an ingredient.
- Published
- December 5, 2018
- Distribution
- Distributed in AK, AZ, CA, CO, MD, ME, M…
View recall →
FDA Recall
🇺🇸 United States
TerminatedTerminated: October 8, 2019Historical recordClass I
Chukar Cherry Company
- Product
- Organic Ultra Dark Vanilla Chocolate Rainier Cherries, Chuka…
- Reason
- Product contains unintentional presence of milk and therefore milk was not listed on the label as an ingredient.
- Published
- December 5, 2018
- Distribution
- Distributed in AK, AZ, CA, CO, MD, ME, M…
View recall →
FDA Recall
🇺🇸 United States
TerminatedTerminated: October 8, 2019Historical recordClass I
Chukar Cherry Company
- Product
- Ultra Dark Chocolate Cocoa Pecans, Chukar Cherries brand, pa…
- Reason
- Product contains unintentional presence of milk and therefore milk was not listed on the label as an ingredient.
- Published
- December 5, 2018
- Distribution
- Distributed in AK, AZ, CA, CO, MD, ME, M…
View recall →
FDA Recall
🇺🇸 United States
TerminatedTerminated: October 8, 2019Historical recordClass I
Chukar Cherry Company
- Product
- Ultra Dark Chocolate Black Forest Cherries, Chukar Cherries…
- Reason
- Product contains unintentional presence of milk and therefore milk was not listed on the label as an ingredient.
- Published
- December 5, 2018
- Distribution
- Distributed in AK, AZ, CA, CO, MD, ME, M…
View recall →
FDA Recall
🇺🇸 United States
TerminatedTerminated: October 8, 2019Historical recordClass I
Chukar Cherry Company
- Product
- Ultra Dark Chocolate Amaretto Rainier Cherries, Chukar Cherr…
- Reason
- Product contains unintentional presence of milk and therefore milk was not listed on the label as an ingredient.
- Published
- December 5, 2018
- Distribution
- Distributed in AK, AZ, CA, CO, MD, ME, M…
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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