FDA Recall
Terminated
Historical recordClass III
Chlorhexidine Gluconate Oral Rinse, 0.12%, 15 mL unit dose cups (NDC 50383-720-15) packaged in 100-count (10 x 10) cups per case pack (NDC 50383-720-18 or 50383-720-19), Rx Only, Hi-Tech Pharmacal Co., Inc., Amityville, NY 11701.
by Akorn, Inc.
- Reason
- Subpotent Drug: Product crystallization with accompanying low out of specification results for chlorhexidine assay.
- Published
- April 4, 2018
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Fosphenytoin Sodium Injection, USP 500 mg PE*/10 mL, Made in India. Distributed by: Amneal Biosciences, Bridgewater, NJ 08807, NDC 70121-1390-1
by Amneal Pharmaceuticals
- Reason
- Presence of particulate matter
- Published
- April 4, 2018
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Evamist (estradiol transdermal spray), 1.53mg estradiol/spray, 0.27 fl oz (8.1 mL) per bottle, Rx Only, Manufactured for Perrigo, Minneapolis, MN 55427. NDC: 0574-2067-27
by Paddock Laboratories, LLC.
- Reason
- Defective Delivery System: Potential that cracks in the vial neck near the crimp may result in product evaporation and/or leaking and the inability to properly dispense product.
- Published
- April 4, 2018
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
Indomethacin Capsules USP, 50 mg, 100-count bottle, Rx Only, Manufactured by: Glenmark Pharmaceuticals Ltd., Colvale-Bardez, Goa 403513, India; Manufactured for: Glenmark Pharmaceuticals Inc., USA, Mahwah, NJ 07430, NDC 68462-302-01.
by Glenmark Pharmaceuticals Inc., USA
- Reason
- Labeling: Incorrect Instructions: bottles incorrectly labeled with the usual adult dosage of "One or two capsules 2 or 3 times a day." rather than the correct usual adult dosage of "One capsule 2 or 3 times a day.
- Published
- April 4, 2018
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
Flucanazole Injection, USP 200 mg in in 100 mL (2 mg/mL), 10 Single Dose Flexible Containers, Rx Only, Manufactured for: Claris Lifesciences, Inc. North Brunswick, NJ 08902 By; Claris Injectables Ltd. Gujarat, India --- NDC 36000-006-10
by Renaissance Lakewood, LLC
- Reason
- Superpotent and Failed Stability Specifications; out of specification results for assay and water vapor permeability
- Published
- April 4, 2018
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
WEIS MARKETS
- Product
- Cole Slaw, Store Made. Packed in deli-style plastic containe…
- Reason
- The ingredient label failed to declare egg because the store-made coleslaw scale label did not list the sub-ingredients of mayonnaise.
- Published
- April 4, 2018
- Distribution
- NY
View recall →
FDA Recall
🇺🇸 United States
Ongoing
Historical recordClass I
Piggie Park Enterprises Inc
- Product
- Maurice's Honey Southern Gold BBQ Sauce; Net Wt. 18 oz. bott…
- Reason
- Undeclared soy and wheat ingredients
- Published
- April 4, 2018
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
Lancaster Fine Foods Inc.
- Product
- 1.5 oz. cup with seal on label reading: Thai Sweet Chili Sa…
- Reason
- The firm received a report that 3 cups labeled as Spicy Mayonnaise Sauce was labeled as Thai Sweet Chili Sauce
- Published
- April 4, 2018
- Distribution
- NY
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
Wegmans Food Markets, Inc.
- Product
- Wegmans Assorted Gyoza (Dumplings), Family Pack, 17 oz. UP…
- Reason
- The product is labeled as Thai Chili Sauce. The product actually contains Spicy Sauce which contains undeclared egg.
- Published
- April 4, 2018
- Distribution
- Wegmans Stores in NY, NJ, PA, VA, MD and…
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
Wegmans Food Markets, Inc.
- Product
- Wegmans Avocado Summer Roll, 2 Pack, 5 oz. UPC: 2-48762-0000…
- Reason
- The product is labeled as Thai Chili Sauce. The product actually contains Spicy Sauce which contains undeclared egg.
- Published
- April 4, 2018
- Distribution
- Wegmans Stores in NY, NJ, PA, VA, MD and…
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
Wegmans Food Markets, Inc.
- Product
- Wegmans Thai Sweet Chili Sauce Cup 1.5 oz. (UPC 7-66630-9802…
- Reason
- The product is labeled as Thai Chili Sauce. The product actually contains Spicy Sauce which contains undeclared egg.
- Published
- April 4, 2018
- Distribution
- Wegmans Stores in NY, NJ, PA, VA, MD and…
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Mondelez Global Llc
- Product
- Sour Patch Kids, 1.9 lb bag
- Reason
- Mondelez Global LLC is initiating a recall because remnants of a half peanut shell were found in two containers of bulk candy from a single lot during the repacking process and the candy is not labeled as containing peanuts. Mondelez Global LLC after an investigation, including inspection of product within in their control from the same lot did not find any other evidence of peanut contamination. The firm believes this is most likely to be an isolated incident and that product on the market is unlikely to contain any peanut pieces and the product is not likely to cause adverse health consequences to peanut allergic consumers. No adverse health events have been reported. Never the less, out of an abundance of caution, we have determined to conduct a voluntary recall to the retail level.
- Published
- April 4, 2018
- Distribution
- The product has been distributed to the…
View recall →
FDA Recall
Terminated
Historical recordClass III
Triamcinolone Acetonide Lotion, USP 0.1%, 60 mL bottle, Rx Only, Marketed by: VersaPharm Incorporated, Marietta, GA 30062; Manufactured by: Ei LLC, Kannapolis, NC 28083, NDC 61748-220-60.
by Akorn, Inc.
- Reason
- Failed Impurities/Degradation Specifications: High out of specification results for an impurity.
- Published
- March 28, 2018
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
Brilliant Blue G for Intraocular Injection 0.5mL vial 0.25 mg/mL Compounded by: Pine Pharmaceuticals 355 Riverwalk Pkwy Tonawanda, NY 14150. NDC 69194-0358-01
by Pine Pharmaceuticals, LLC
- Reason
- Labeling: Label Mix-Up: Brilliant Blue G was labeled with an inaccurate auxiliary label which contained active/inactive ingredient information for incorrect product.
- Published
- March 28, 2018
- Distribution
- NY only
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass III
Ikea North America Srvcs Inc
- Product
- Pink flexible, plastic package: Godis Paskkyckling Marshm…
- Reason
- Possible Pest Contamination at production facility.
- Published
- March 28, 2018
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Food and Beverage Inc.
- Product
- Name: Trader Joe s Chocolate Chip Cookies SKU 68075 Net Wei…
- Reason
- Food & Beverage Inc., dba Chris's Cookies has initiated a recall of Trader Joe s Peanut Butter Sutter s Formula Cookies (Trader Joes SKU 93307) that was packed in a Trader Joes branded Chocolate Chip Cookie bag, and sent out as Chocolate Chip Cookies. Please note the Chocolate Chip Cookie bag has a statement on the back that says: MAY CONTAIN TRACES OF PEANUTS AND TREE NUTS , but since the wrong product packed is based almost completely in peanut this could represent a bigger risk for those who have peanuts allergies. Thus, prompting the firm to error on the side of public safety and initiate a recall.
- Published
- March 28, 2018
- Distribution
- The product was distributed to the follo…
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
ASR GROUP INTERNATIONAL INC
- Product
- Tank Truck Medium Invert Syrup (403777)
- Reason
- Foreign material (metal) in product.
- Published
- March 28, 2018
- Distribution
- Multiple states
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
ASR GROUP INTERNATIONAL INC
- Product
- Tank Truck #2 Sugar Syrup (403764)
- Reason
- Foreign material (metal) in product.
- Published
- March 28, 2018
- Distribution
- Multiple states
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
ASR GROUP INTERNATIONAL INC
- Product
- Tank Truck #1 Sugar Syrup (403763)
- Reason
- Foreign material (metal) in product.
- Published
- March 28, 2018
- Distribution
- Multiple states
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
WEIS MARKETS
- Product
- Dried Beef Party Rye Dip; Ingredients: Hellman's Mayonaise,…
- Reason
- Label did not list sub-ingredients for mayo and sour cream. It contains undeclared egg and milk. The firm found a 2nd PLU which was not corrected. Recall of Weis Dried Beef Party Rye Dip was expanded to include 2nd PLU.
- Published
- March 28, 2018
- Distribution
- NY and PA
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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