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Breads from Anna Yeast Free Mix (Wholesome) – undeclared flaxseed (2019)

Undeclared Allergen

Undeclared flaxseed. Flaxseed was used in the products but is not listed on the product labels.

Class IIILow

FDAMar 31, 2019Nationwide• Wholesome Treats, Inc.

Clonidine HCL Injection (X-Gen) – Labeling Error (2019)

Labeling: Label Error on Declared Strength: Side carton panel incorrectly lists the concentration as "500 mcg Clonidine Hydrochloride" rather than the correct concentration of "100 mcg Clonidine Hydrochloride" per mL.

Class IIILow

FDA

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Breads from Anna Yeast Free Mix (Wholesome) – undeclared flaxseed (2019)

Clonidine HCL Injection (X-Gen) – Labeling Error (2019)

Nystatin Oral Suspension (Akorn) – Impurity Specification (2019)

Thallous Chloride Injection (GE Healthcare) – Chemical Contamination (2019)

Biotin Injection (Auro Pharmacies) – pH Specification Failure (2019)

Probiotic Capsules (Walgreens) – incorrect strain (2019)

Diclofenac Sodium Solution (Ingenus) – Leaking Bottles (2019)

Cleocin Phosphate Injection (Pfizer) – Impurity Specification Failure (2019)

Repairwear Laser Focus Cream (Estee Lauder) – Ineffective Seal (2019)

Clindamycin Injection (Pfizer) – Impurity Specification Failure (2019)

Cleocin Phosphate Injection (Pfizer) – Impurity Specification Failure (2019)

Clindamycin Injection (Pfizer) – Impurity Specification Failure (2019)

Clindamycin Injection (Pfizer) – Impurity Specification Failure (2019)

Cleocin Phosphate Injection (Pfizer) – Impurity Specification Failure (2019)

Testosterone Topical Solution (Lupin) – Defective Pump (2019)

Lansoprazole Orally Disintegrating Tablets (Teva) – Subpotent Drug (2019)

Quinoa (Kroger) – pesticide contamination (2019)

Mirapex Tablets (Boehringer) – Weight Specification Failure (2019)

ATHLETICARE Hand Soap (Petra Hygienic) – Ingredient Violation (2019)

Oxybutynin Chloride Tablets (AVKARE) – Dissolution Failure (2019)