FDA Recall
Terminated
Historical 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
Terminated
Historical 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
Terminated
Historical 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
Terminated
Historical 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
Terminated
Historical 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
Terminated
Historical 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
Terminated
Historical 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
Terminated
Historical 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
Terminated
Historical 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
Terminated
Historical 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
Terminated
Historical 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
Terminated
Historical 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
Terminated
Historical 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
Terminated
Historical recordClass II
ConAgra Foods, INc.
- Product
- Duncan Hines Signature Confetti Cake cake mix 15.25oz.…
- Reason
- positive finding of Salmonella in a retail sample
- Published
- December 5, 2018
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
ConAgra Foods, INc.
- Product
- Duncan Hines Classic Butter Golden cake mix 15.25oz. 12…
- Reason
- positive finding of Salmonella in a retail sample
- Published
- December 5, 2018
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
ConAgra Foods, INc.
- Product
- Duncan Hines Classic Classic Yellow cake mix 15.25oz. 1…
- Reason
- positive finding of Salmonella in a retail sample
- Published
- December 5, 2018
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
ConAgra Foods, INc.
- Product
- Duncan Hines Classic Classic White cake mix 15.25oz. 12…
- Reason
- positive finding of Salmonella in a retail sample
- Published
- December 5, 2018
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Clopidogrel Tablets, USP, 300 mg, 30 (5 x 6 unit-dose) count blister pack, Rx only, Manufactured by Dr. Reddy's Laboratories Limited, Srikakulam - 532 409, India, NDC 55111-671-31
by Dr. Reddy's Laboratories, Inc.
- Reason
- Failed Dissolution Specification: Out-of-Specification results were observed for dissolution at 18th month stability testing.
- Published
- November 28, 2018
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Medi-Stat Foam, Antimicrobial Hand Soap, Chloroxylenol 0.5%, 1250 mL (42.3 fl oz), OTC, Ecolab, 370 Wabasha Street N, St. Paul, MN 55102, NDC 47593-503-59
by Ecolab Inc
- Reason
- Labeling: Label mix-up - the label on the product may not match the formula in the bottle.
- Published
- November 28, 2018
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Equi-Soft Foam, Antimicrobial Hand Soap, 0.55% Benzalkonium Chloride, 25 fl oz (750 mL), OTC, Ecolab, 370 Wabasha Street N, St. Paul, MN 55102, NDC 47593-521-41
by Ecolab Inc
- Reason
- Labeling: Label mix-up - the label on the product may not match the formula in the bottle.
- Published
- November 28, 2018
- 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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