Tea Wafer - Vanilla Almond [Two sizes: retail package of 8 wafers (7 oz) and retail gift package of 2 wafers (2 oz)]
Sacramento Cookie Factory
🍎 Food Class I - Dangerous
Undeclared allergen (milk)
All Recalls
95,114 total recalls in our database
Belgian Yummies Homemade Ice Cream Horchata Gelato. Packaged in 4.75 Liter gray pan.
Belgian Yummies
🍎 Food Class I - Dangerous
Undeclared Allergen: milk and wheat.
D-LO's Delightful Gourmet Cheesecake, Pistachio, 142g single serve UPC 8 60007 40398 9, and 678g six serving UPC 8 60007 40395 8, both serving sizes in clear plastic container with hinged lid
D-lo's Gourmet Cheesecake
🍎 Food Class I - Dangerous
Undeclared wheat, soy, colors (yellow 5 and blue 1), incomplete contains statement
Sapropterin Dihydrochloride Powder for Oral Solution 100mg, 30 individual packets per carton, Rx Only, Distributor: Dr. Reddy's Laboratories Inc., Princeton, NJ 08540, Made in India, NDC 43598-477-30.
Dr. Reddy's Laboratories
💊 Drugs Class I - Dangerous
Sub-potent Drug; powder discoloration associated with decreased potency
💊 Drugs Class I - Dangerous
Defective Container: yellow-colored spike from cap lodged in the nozzle. Firm received several complaints from customers.
Amphotericin B Liposome for Injection, 50mg vials, Rx only, Distributed by: Sun Pharmaceutical Industries, Inc. Cranbury, NJ 08512, Manufactured by: Sun Pharmaceutical Medicare Limited, Baska Ujeti Road, Ujeti Halol-389350, Gujarat, India. NDC 62756-233-01
SUN PHARMACEUTICAL INDUSTRIES
💊 Drugs Class I - Dangerous
Out of specification for assay
Javygtor (sapropterin dihydrochloride) Powder for Oral Solution 100mg, 30 individual packets per carton, Rx Only, Distributor: Dr. Reddy's Laboratories Inc., Princeton, NJ 08540 Made in India, NDC 43598-097-30.
Dr. Reddy's Laboratories
💊 Drugs Class I - Dangerous
Sub-potent Drug; powder discoloration associated with decreased potency
💊 Drugs Class I - Dangerous
Discoloration: Dotted and yellow spots on tablets
💊 Drugs Class I - Dangerous
Presence of Foreign Tablets: Manufacturer received a report from a Pharmacist who reported finding a tablet of baclofen in a bottle of 1000-count tramadol
traMADol Hydrochloride Tablets, USP 50 mg, 1000-count bottle, Rx Only, Distributed by: Advagen Pharma Limited, 666 Plainsboro Road Suite 605, Plainsboro, NJ, 08536, USA, Manufactured by: Rubicon Research, Private Limited, Ambernath, Dist. Thane, 421506 India NDC 72888-080-00
Rubicon Research Private Limited
💊 Drugs Class I - Dangerous
Presence of Foreign Tablets: Pharmacist reported a tablet of baclofen in a bottle of 1000-count tramadol
💊 Drugs Class I - Dangerous
Discoloration: Dotted and yellow spots on tablets
Duloxetine Delayed-Release Capsules, USP, 60 mg, 90-count bottles, Rx Only, Mfr. by: Towa Pharmaceutical Europe, S.L. Martorelles, (Barcelona), Spain, Dist. by: Breckenridge Pharmaceuticals, Inc., Berkeley Heights, NJ 07922, NDC: 51991-748-90.
Breckenridge Pharmaceutical
💊 Drugs Class I - Dangerous
CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit
💊 Drugs Class I - Dangerous
CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit
Duloxetine Delayed-Release Capsules, USP, 20 mg, , 500-count bottles, Rx Only, Mfr. by: Towa Pharmaceutical Europe, S.L. Martorelles, (Barcelona), Spain, Dist. by: Breckenridge Pharmaceuticals, Inc., Berkeley Heights, NJ 07922, NDC 51991-746-05.
Breckenridge Pharmaceutical
💊 Drugs Class I - Dangerous
CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit
Sodium Sulfacetamide 10% - Sulfur 5% Cleanser, Rx Only, 6 oz (170.3 g) Bottle, Manufactured for Acela Pharmaceuticals, LLC Alphareta, GA 30005, NDC 42192-136-06
Acella Pharmaceuticals
💊 Drugs Class I - Dangerous
Subpotent drug
🏥 Medical Devices Class I - Dangerous
Tri-Ball Tunneler may contain loosely affixed metal shavings, potential for the metal shaving to embolize, possibly requiring removal via surgical procedure.
Evidence MultiSTAT with software v 3.7-Analyzer intended for the qualitative determination of parent drug molecule and metabolites of drugs in human urine Catalog Number: EV4115
Randox Laboratories
🏥 Medical Devices Class I - Dangerous
Foam gasket on the Evidence MultiSTAT chip heater assembly may not perform as expected. Foam that is not functioning as expected may cause light to leak into the Charged Coupled Device (CCD) Camera during imaging. This will affect the testing and may delay in reporting results.
🏥 Medical Devices Class I - Dangerous
Tri-Ball Tunneler may contain loosely affixed metal shavings, potential for the metal shaving to embolize, possibly requiring removal via surgical procedure.
Safety Information: Complaints describe complications/adverse events that include pain, infection, rash, device migration, device erosion, seroma, discomfort, or other complications from feeling the device in the breast, and the need for additional medical treatment to remove the device
🏥 Medical Devices Class I - Dangerous
X-ray system C-arm may experience uncontrolled motion if 1) AC motor controller firmware has a faulty setting, 2) the Motor/gear assembly is worn, 3) CAT movement is driven at maximum speed and angulated more than 75 deg. from vertical, and 4) the emergency stop or touch guard is activated during the breaking sequence, which could lead to the C-arm hitting the patient or operator.