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Prostaglandin Injectable (Pharmacy Innovations) – sterility concerns (2022)

Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility.

FDADec 22, 2022Nationwide• Pharmacy Innovations

Timolol Maleate (Apotex) – Stability Specification Failure (2022)

Failed Stability Specifications: Out of specification for weight loss at the 18-month stability timepoint and projected weight loss of 21.1% at shelf life.

Class IIILow

FDADec 21, 2022Nationwide• Apotex Corp.

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Prostaglandin Injectable (Pharmacy Innovations) – sterility concerns (2022)

Timolol Maleate (Apotex) – Stability Specification Failure (2022)

Rifampin Capsules (RemedyRepack) – Impurity Specifications (2022)

Rifampin Capsules USP (Amerisource) – Impurity Specifications (2022)

Epinephrine L-Adrenaline (Spectrum) – Product Discoloration (2022)

Epinephrine L-Adrenaline (Spectrum) – Product Discoloration (2022)

Ganciclovir Injection (Hikma) – Label Mix-up (2022)

Glycopyrrolate Tablets (Aurolife) – Impurity Specifications (2022)

Tattoo Numbing Cream (Sainite) – child-resistant packaging (2022)

Rifampin Capsules (Lupin) – Impurity Specifications (2022)

Thiamine Hydrochloride Injection (McGuff) – Particulate Matter (2022)

Thiamine Hydrochloride 3000 mg (McGuff) – Foreign Substance (2022)

Quinapril Tablets 40mg (Lupin) – Impurity Limit Exceeded (2022)

Quinapril Tablets 20mg (Lupin) – Impurity Limit Exceeded (2022)

Lacosamide Oral Solution (Camber) – Excipient Specification Fail (2022)

Advil Liqui-Gels Minis (Haleon) – Illegible Label (2022)

Advil Liqui-Gels (Haleon) – Illegible Label (2022)

Advil Tablets 200mg (Haleon) – Illegible Label (2022)

Desmopressin Acetate Tablet (RemedyRepack) – Subpotent Drug (2022)

Iohexol Injection (BayCare) – Mislabeled Strength (2022)