Plastic material. The piece of plastic material was detected in a 40lb. cheese block and smaller fragments of the plastic material may be found in the cheese slices.

Class IIModerate

FDAMay 30, 2024IN, UT, WA• Tillamook County Creamery Association

Gas Relief Drops (Denison) – cGMP Deviations (2024)

cGMP deviations: Test results confirmed aypical Burkholderia Cepacia were a result of personnel error.

Class IIModerate

FDAMay 28, 2024Nationwide• Denison Pharmaceuticals, LLC

Petroleum Jelly (Consumer Product) – Labeling Error (2024)

Labeling: Label Mix up; product labeled as pure white petroleum jelly actually contains petroleum jelly with Lavendar and Chamomile

Class IIModerate

FDAMay 28, 2024Nationwide• Consumer Product Partners, LLC

Phenazopyridine HCl Tablets (Winder) – Product Mix Up (2024)

Product Mix Up. A bottle of Phenazopyridine HCl tablets USP 100 mg contained Phenobarbital tablets 16.2 mg.

Class IIModerate

FDAMay 28, 2024Nationwide• Winder Laboratories, LLC

Ground Cinnamon (Spice Class) – high lead levels (2024)

Product contains elevated levels of lead (2,040ppb).

Class IIModerate

FDAMay 28, 2024NY• American Spice LLC

Suntegrity Sunscreen (Synchronicity) – CGMP Deviations (2024)

CGMP Deviations

Class IIModerate

FDAMay 24, 2024Nationwide• SYNCHRONICITY SPA INC, DBA SUNTE

Dexamethasone Injection (Eugia) – Impurity Specifications (2024)

Failed Impurities/Degradation Specifications: impurity sulfonic acid adduct of dexamethasone phosphate results were above spec.

Class IIModerate

FDAMay 23, 2024Nationwide• Eugia US LLC

Zoledronic Acid Injection (Dr. Reddy's) – Sterility Concern (2024)

Lack of Assurance of Sterility: Leaking vials

Class IIModerate

FDAMay 23, 2024Nationwide• Dr. Reddy's Laboratories, Inc.

Cheddar Cheese Curds (Moore Family Farms) – High Coliform Risk (2024)

E. coli

High coliform and generic E. coli count

Class IIModerate

FDAMay 23, 2024IA• Moore Family Cheese LLC

OSSOS-SANS Tablets (MexHealth) – Undeclared Ingredients (2024)

Undeclared Allergen

Marketed Without An Approved NDA/ANDA: FDA laboratory analysis found the product to contain undeclared diclofenac and methocarbamol,

Class IIModerate

FDAMay 22, 2024Nationwide• MexHealth LLC

Cinnamon Powder (Shahzada) – Elevated Lead Levels (2024)

Product contains elevated levels of lead (2,030 ppb)

Class IIModerate

FDAMay 21, 2024CT, MA, NJ +1 more• Advance Food International Inc.

Labetalol Hydrochloride Injection (Pfizer) – Crimp Seal Issue (2024)

Lack of Assurance of Sterility-The potential for incomplete crimp seals.

Class IIModerate

FDAMay 20, 2024Nationwide• Pfizer Inc.

Buprenorphine Hydrochloride Injection (Pfizer) – Crimp Seal Issue (2024)

Lack of Assurance of Sterility-The potential for incomplete crimp seals.

Class IIModerate

FDAMay 20, 2024Nationwide• Pfizer Inc.

Acetaminophen Tablets (Contract Pharmacal) – Tablet Discoloration (2024)

Discoloration: Brownish tablets

Class IIModerate

FDAMay 20, 2024MI• Contract Pharmacal Corporation

Cathflo Activase (Genentech) – Sterility Concern (2024)

Lack of Assurance of Sterility: Deformed stoppers observed during filling operations for Cathflo Activase.

Class IIModerate

FDAMay 20, 2024Nationwide• Genentech, Inc.

Duloxetine Capsules (Breckenridge) – Impurity Concern (2024)

CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit

Class IIModerate

FDAMay 17, 2024Nationwide• Breckenridge Pharmaceutical, Inc

Macaroni Salad (Reser's) – Undeclared Wheat (2024)

Undeclared Gluten

Undeclared Wheat. Aldi Macaroni Salad was mislabeled as Coleslaw and Coleslaw label does not declare wheat. Macaroni (pasta) is visible through a clear plastic package.

Class IIModerate

FDAMay 17, 2024AL, CT, FL +13 more• Reser's Fine Foods, Inc.

Plant-Rich Meal (Once Upon a Farm) – Listeria Risk (2024)

Listeria

Potential contamination with Listeria monocytogenes

Class IIModerate

FDAMay 17, 2024AL, FL, GA +7 more• ONCE UPON A FARM PBC

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