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Showing 661–680 of 3363 results

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Ultimate Blend Detox Cherry (Zydot) – Undeclared Ingredients (2022)

The ingredient list did not declare the preservatives (potassium sorbate, sodium benzoate) and food coloring (R40) in the product.

FDAMay 6, 2022Nationwide• Zydot Unlimited, Inc

Supple Bears Gummies (6174 Industries) – Gluten Mislabeled (2022)

Product was labeled as "gluten free" and it may contain gluten.

FDAMay 5, 2022AR, ID, IL +5 more• 6174 Industries, LLC

Sirolimus Oral Solution (Apotex) – Dissolution Failure (2022)

Failed Dissolution Specifications: Sirolimus Oral Solution recalled due to lot RZ1598 exceeded the specification limit at the 14-month timepoint.

Class IIILow

FDAMay 3, 2022Nationwide• Apotex Corp.

Nitrofurantoin Capsules (American Health) – Dissolution Failure (2022)

Failed Dissolution Specifications: Nitrofurantoin Capsules recalled due to dissolution failure at 0-time of the repackaged lot. Drug release results were above specification at 0-time.

FDAMay 3, 2022Nationwide• American Health Packaging

Bupropion Hydrochloride Tablets (Sun Pharmaceutical) – Foreign Substance (2022)

Presence Of Foreign Substance: Customer complaint for the presence of dark, gritty substance found within the bottle which was determined to be activated carbon from the desiccant canister inside the bottle.

FDAApr 29, 2022Nationwide• SUN PHARMACEUTICAL INDUSTRIES INC

Bupropion Hydrochloride Tablets (Sun Pharmaceutical) – Foreign Substance (2022)

Presence Of Foreign Substance: Customer complaint for the presence of dark, gritty substance found within the bottle which was determined to be activated carbon from the desiccant canister inside the bottle.

FDAApr 29, 2022Nationwide• SUN PHARMACEUTICAL INDUSTRIES INC

Make Out Ready Lip Balm (Eco Lips) – Mislabeled Ingredients (2022)

Mislabeling: The active ingredient list on the label does not match the product's actual ingredients Specifically, the label states Octinoxate 7.5% and Oxybenzone 3%, while the product therein is made with Octinoxate 7.5%, Octisalate 5%, Octocrylene 5%, and Avobenzone 3%.

FDAApr 29, 2022CA• Eco Lips, Inc

Milk & Dark Chocolate Caramels (R & S Roberts) – undeclared soy (2022)

Undeclared Soy Lecithin. Firm used Canola Oil spray as a releasing agent but finished products labels do not declare Soy Lecithin.

FDAApr 27, 2022IN, WA• R & S Roberts Enterprises, Inc.

Milk & Dark Chocolate Himalayan Salted Caramels (R & S Roberts) – undeclared soy (2022)

Undeclared Soy Lecithin. Firm used Canola Oil spray as a releasing agent but finished products labels do not declare Soy Lecithin.

FDAApr 27, 2022IN, WA• R & S Roberts Enterprises, Inc.

Milk & Dark Chocolate Caramel Macchiato (R & S Roberts) – undeclared soy (2022)

Undeclared Soy Lecithin. Firm used Canola Oil spray as a releasing agent but finished products labels do not declare Soy Lecithin.

FDAApr 27, 2022IN, WA• R & S Roberts Enterprises, Inc.

Open Nature Cough Drops (Bestco) – Subpotent Menthol (2022)

Subpotent drug: Low OOS for menthol content at the three month room temperature.

FDAApr 27, 2022CA, ID, OK +1 more• Bestco LLC

Milk & Dark Chocolate Sea Salt Healthy Bites (R & S Roberts) – undeclared soy (2022)

Undeclared Soy Lecithin. Firm used Canola Oil spray as a releasing agent but finished products labels do not declare Soy Lecithin.

FDAApr 27, 2022IN, WA• R & S Roberts Enterprises, Inc.

Milk & Dark Chocolate Healthy Bites (R & S Roberts) – undeclared soy (2022)

Undeclared Soy Lecithin. Firm used Canola Oil spray as a releasing agent but finished products labels do not declare Soy Lecithin.

FDAApr 27, 2022IN, WA• R & S Roberts Enterprises, Inc.

Milk & Dark Chocolate Sea Salt Caramels (R & S Roberts) – undeclared soy (2022)

Undeclared Soy Lecithin. Firm used Canola Oil spray as a releasing agent but finished products labels do not declare Soy Lecithin.

FDAApr 27, 2022IN, WA• R & S Roberts Enterprises, Inc.

Roasted Peanuts (Korica) – Unapproved Color (2022)

Product contains cyclamate, an unapproved color.

FDAApr 18, 2022CA, CT, FL +9 more• Rong Shing Trading NY Inc

Blackberries (Driscoll's) – Pesticide Violation (2022)

California Department of Pesticide Regulation detected the presence of Formetante HCI. This pesticide has a non-tolerance for blackberries.

FDAApr 15, 2022CA, FL, IL +7 more• Driscoll's Inc.

Lidocaine Oral Solution (Akorn) – Viscosity Specification Failure (2022)

Failed viscosity specification - product was below specificcation

FDAApr 15, 2022Nationwide• Akorn, Inc.

Phenobarbital Elixir (Monarch PCM) – Alcohol Content Excess (2022)

Does Not Meet USP or OTC Monograph: Product exceeds USP specification for alcohol content

FDAApr 14, 2022TN• Monarch PCM, LLC

Ipratropium Bromide/Albuterol Sulfate Inhalation Solution (Mckesson) – Temperature Abuse (2022)

cGMP deviations: Temperature abuse

FDAApr 13, 2022Nationwide• Mckesson Medical-Surgical Inc. Corporate Office

Cyanocobalamin Injection (American Health) – Subpotent Drug (2022)

Subpotent Drug: Out of specification for assay.

FDAApr 12, 2022AL• American Health Packaging

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