FDA Recalls in 2021
3,248 recalls found
December 2021
Rompe Pecho Max Multi-Symptoms Maximum Strength, 8 Fl. Oz. (237 mL) bottles, Distributed by: Efficient Laboratories, Inc. Miami, FL 33166 UPC 0 00856 00309 5, NDC 58593-828-08
Microbial Contamination of Non-Sterile Products
Penicillin V Potassium for Oral Solution, USP 125 mg (200,000 U) per 5 mL a) 100 mL (NDC 00093-4125-73) and b) 200 mL (NDC 00093-4125-74) (when mixed) bottles, Rx Only, Manufactured For: Teva Pharmaceuticals USA, Inc. North Wales, PA 19454
Subpotent
Hand Sanitizer Foam (ethyl alcohol), 62% v/v, packaged in a) 1.5 Oz. cans, NDC 53329-970-12; b) 8 Oz. (227 g) cans, NDC 53329-970-08; and c) 16 Oz. (453 g) cans, NDC 53329-970-06; Manufactured for: Medline Industries, Inc., Northfield, IL 60093.
Defective Container: Customer complaints for leaking bottles and dispensing issues.
Fexofenadine Hydrochloride Tablets, 60 mg, 500 Tablets per bottle, Distributed by: Major Pharmaceuticals, 17177 N. Laurel Park Drive, Suite 233, Livonia, MI 48152 NDC 0904-6979-40
Failed Impurities/Degradation Specifications
Moxifloxacin, 1 mg/mL, 1mL in 2mL vial, solution for intracameral injection, 10 vials/carton, Rx only, Leiters 13796 Compark Blvd, Englewood, CO 80112, (800) 292-6772, NDC 71449-096-42
Labeling: Label Mix-up: Vials labeled as moxifloxacin 1 mg/mL may actually contain moxifloxacin 5 mg/mL
Rompe Pecho Ex Expectorant, packaged in a) 4 Fl. Oz. (118 mL) bottles NDC 58593-829-04 and b) 6 Fl. Oz. (178 mL) bottles NDC 58593-829-06, Distributed by Efficient Laboratories, Inc. Miami, FL 33166
Microbial Contamination of Non-Sterile Products
Rompe Pecho CF Cold & Flu Advanced Formula, 6 Fl. oz. (178 mL) bottles, Distributed by: Efficient Laboratories, Inc. Miami, FL 33166, NDC 58593-235-06
Microbial Contamination of Non-Sterile Products
Rompe Pecho DM, 6 Fl Oz (178 mL) bottles, Distributed by: Efficient Laboratories, Inc. Miami, FL 33166, NDC 58593-275-06
Microbial Contamination of Non-Sterile Products
two-bite carrot cake cupcakes 10 oz. UPC 7 70981 05525 1 Kimberley's bakeshoppe carrot cake filled gourmet cupcakes 11.5 oz. UPC 7 70981 31026 8
Potential for metal in product
Cesarina Cookies, Assorted Cookies, Net Weight 16oz (453.59g)
Undeclared Milk
Kimberley's bakeshoppe vanilla mini Frosted soft Sugar Cookies 9.4 oz. UPC 7 70981 30310 9
Potential for metal in product
two-bite vanilla & chocolate cupcakes 20 oz. UPC 7 70981 03408 9 Favorite Day Bakery chocolate & vanilla mini cupcakes 10 oz. UPC 0 85239 12580 9
Potential for metal in product
two-bite vanilla & chocolate cupcakes 10 oz. UPC 7 70981 04502 3 20 oz. UPC 7 70981 03107 1 meijer mini assorted cupcakes with Holiday inspired sprinkle blend 20 oz. UPC 7 08820 40243 0 Kimberley's bakeshoppe vanilla & chocolate cupcakes 22 oz. UPC 7 70981 31122 7
Potential for metal in product
Wondershop at Target Frosted Sugar Cookies 13.5 oz. UPC 0 85239 13621 8
Potential for metal in product
NL Vanilla Iced Assorted cupcakes 24PK 983352 15 lbs. case UPC 1 07 70981 03948 7
Potential for metal in product
Cesarina Cookies, Tutti Frutti Cookies, Net Weight 16oz (453.59g)
Undeclared Milk
Wondershop at Target vanilla mini cupcakes 10 oz. UPC 0 85239 03474 3
Potential for metal in product
Kimberley's bakeshoppe vanilla mini Frosted soft Sugar Cookies 9.4 oz. UPC 7 70981 30312 3
Potential for metal in product
Cesarina Cookies, Mini Linzer Tart, Apricot Raspberry, Net Weight 16oz (453.59g)
Undeclared Milk
Favorite Day Bakery madeleine & brownie tiny treats 11 oz. UPC 0 85239 16499 0
Potential for metal in product
Kimberley's Bakeshoppe vanilla cupcakes 11.2 oz. UPC 7 70981 31213 2
Potential for metal in product
Dakota Tom's and Market Fresh branded Chicken Salad Croissant sandwiches. Net Wt. 6.5 oz. UPC 37296-10100, Dakota Toms, Box 271, Corsica, SD 57328.
Sandwiches contain undeclared egg and milk.
Golden Flax Seed Scala Bread,
Contains undeclared sesame seeds
Cesarina Cookies, Raspberry Sandwich Chocolate Dipped, Net Weight 16oz (453.59g)
Undeclared Milk
Kimberley's bakeshoppe triple chocolate filled gourmet cupcakes 11.7 oz. UPC 7 70981 31001 5 and 7 70981 31116 6 Favorite Day Gourmet Triple Chocolate filled cupcakes 11.7 oz. UPC 0 85239 42017 1
Potential for metal in product
Coca-Cola cola; 12 oz. aluminum can; 12-pack fridge pack/case
Potential presence of foreign matter in container.
Kimberley's bakeshoppe Frosted soft Sugar Cookies 13.5 oz. UPC 7 70981 30102 0
Potential for metal in product
two-bite red velvet cupcakes 10 oz. UPC 7 70981 05520 6 Marketside red velvet cupcakes 10 oz. UPC 6 81131 10150 9 11.7 oz. UPC 6 81131 24843 3 NL two-bite Red Velvet Premium Cupcakes 12PK 05620 7.52 lbs. case UPC 1 07 70981 05620 0 Favorite Day Gourmet red velvet filled cupcakes 11.7 oz. UPC 0 85239 42016 4 Kimberley's bakeshoppe red velvet filled gourmet cupcakes 11.7 oz. UPC 7 70981 31005 3
Potential for metal in product
Favorite Day Gourmet Vanilla filled cupcakes 11.7 oz. UPC 0 85239 42018 8 Kimberley's bakeshoppe Vanilla bean filled gourmet cupcakes 11.7 oz. UPC 7 70981 31117 3 Kimberley's bakeshoppe vanilla filled gourmet cupcakes 11.7 oz. UPC 7 70981 31003 9
Potential for metal in product
Flora PASTRIES FIOCHETTO Assorted Flavors Apricot and Raspberry, Net. Wt. 16 oz (454g)
Undeclared Milk
Flora PASTRIES BUTTER COOKIES Assorted Varieties, Net. Wt. 16 oz (454g)
Undeclared Milk
NL two-bite Cream Cheese Iced Cinnamon Roll 08030 16.93 lbs. case UPC 1-07-70981-08030-4
Potential for metal in product
Freshness Guaranteed Cookies N' Creme Tiny Pies 12.7 oz. UPC 0 78742 37636 3
Potential for metal in product
Flora CHOCOLATE SANDWICH Chocolate Dipped with Sprinkles, Net. Wt. 16 oz (454g)
Undeclared Milk
Give and Go Prepared Foods Corp. Kids Cupcakes chocolate & vanilla kids cupcakes 21.9 oz. UPC 7 70981 31091 6
Potential for metal in product
Flora PASTRIES RASPBERRY SANDWICH Chocolate Dipped with Sprinkles, Net. Wt. 16 oz (454g)
Undeclared Milk
two-bite chocolate cupcakes 10 oz. UPC 7 70981 04460 6
Potential for metal in product
Kimberley's bakeshoppe Caramel Macchiato filled gourmet cupcakes 11.7 oz. UPC 7 70981 31087 9
Potential for metal in product
two-bite vanilla & chocolate cupcakes 10.5 oz. UPC 7 70981 03468 3 Sweet P's Bake Shop chocolate & vanilla cupcakes 10.5 oz. UPC 0 11225 54723 2
Potential for metal in product
Signature Select Pumpkin Spice mini cupcakes 10 oz. UPC 0 21130 98478 7 Bake Shop Pumpkin Spice mini cupcakes 10 oz. UPC 4 09910 02729 56 two-bite Pumpkin Spice cupcakes 10 oz. UPC 7 70981 05551 0
Potential for metal in product
Cesarina Cookies, Sesame Seed Cookies, Net Weight 16oz (453.59g)
Undeclared Milk
Freshness Guaranteed Black Forest Tiny Pies 18.5 oz. UPC 0 78742 37635 6
Potential for metal in product
DoctoRx's Optimal Formula, Dry Eye Formula, Ocular Support Softgel, 60 Softgels/Dietary Supplement
Undeclared fish allergen
Black Rifle Coffee Mac V Whole Bean Coffee 12oz PET bags 40 bags per case
Possible plastic within final product packaging.
two-bite vanilla cupcakes 10 oz. UPC 7 70981 03460 7 Horneaditos cupcake de vainilla 10 oz. UPC 7 70981 04125 4
Potential for metal in product
Sprite; 12 oz. aluminum can; 12-pack fridge pack/case
Potential presence of foreign matter in container.
Karl Storz Udel Sterilization Tray Instructions for Use, Tray Part Number/Description: 39301ACTS/CAMERA TRAY (STERRAD, INLINE CAMERA HEADS); 39301AS/RIGID TELESCOPE TRAY (STERRAD, 2 RIGID SCOPES 4MM X 18CM); 39301BCTS/CAMERA TRAY (INLINE/C-MOUNT CAMERA HEADS); 39301BS/RIGID TELESCOPE TRAY (STERRAD, 2 RIGID SCOPES 5MM X 35CM); 39301C1S/RIGID TELESCOPE TRAY (STERRAD, 1 RIGID SCOPE & LT CABLE); 39301CS/RIGID TELESCOPE TRAY (STERRAD, 2 RIGID SCOPE 10MM X 31CM); 39301DS/RIGID TELESCOPE TRAY (STERRAD,
To ensure sterilization effectiveness, sterilization tray instructions for use were updated and now state 1) udel trays may be used with flexible endoscopes with lumen diameters greater-than-or-equal to 1.2mm and maximum length of 845mm and 2) ethylene oxide is excluded as a sterilization modality.
On 10/15/21 correction notices were mailed to customers. Customers were asked to do the following: 1) Ensure all personnel in your organization review this letter and the current instructions for use. If you have previously sold or transferred affected devices to a third party, please forward this notice to all such third parties. 2) Discard any prior versions of the instructions for use. 3) Complete and return the acknowledgment form. Customers with medical or safety-related inquiries can contact Medical Affairs at 1-800-649-8852 or medicalaffairs@karlstorz.com. Customers with questions about the correction communication are encouraged to call 1-866-913-0667 or email karlstorz7824@stericycle.com.
iDesign, Model - G300: System AWS (International), System AWS (China), Advanced WaveScan Studio (United States); iDesign Refractive Studio Aberrometer (International) and (United States), Model: G301
Aberrometer and precision laser systems are affected by a remote code execution vulnerability existing when the Microsoft Windows Print Spooler service is enabled, and improperly performs privileged file operations. This could be exploited to run arbitrary code with SYSTEM privileges, allowing for program installation; view/change/deleting data; or creation of new accounts with full user rights.
On 09/02/21, Microsoft "PrintNightmare" Vulnerability notices were sent to customers informing them of the upcoming software patches to remediate the vulnerability. This notice was posted on the recalling firm's website in the Security Advisories section. On 10/21/21 correction notices started being sent to customers. Customers were informed that Technical Service Representatives would contact then to schedule installation of the Windows OS patch. Customers were asked to do/ensure the following: 1) Complete the customer reply form, 2) To safeguard patients form potential harm and to inform them what to do in the event of product malfunction, customers were directed to specific parts of the Instructions for Use. 3) Confirm all measurements against baseline pre-operative manifest refraction and do not proceed when outside of recommended limits of difference, for sphere, cylinder and axis, as specified in the operators manual and training material. 4) Maintain manual records of patient measurements. 5) Ensure you comply with obligations under applicable privacy laws relating to putting in place safeguards in connection with personal information for patients. Customers with additional questions were encouraged to call Technical Support at 1 (800)- 511-0911.
Marketside strawberry shortcake cupcakes 11.7 oz. UPC 6 81131 24844 0
Potential for metal in product
Kimberley's bakeshoppe Christmas cupcakes with rings 22 oz. UPC 7 70981 31188 3
Potential for metal in product