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Difluprednate Ophthalmic Emulsion (CIPLA) – Container Defect (2022)

Lack of Assurance of Sterility: customer complaint for defective container where breakage of the protective cap exposes tip of eye drop which could compromise sterility.

Class IIModerate

FDAJul 14, 2022Nationwide• CIPLA

Lansoprazole Orally Disintegrating Tablets 35mg (Dr. Reddy's) – Dissolution Failure (2022)

FAILED DISSOLUTION SPECIFICATIONS

Class IIModerate

FDAJul 13, 2022Nationwide• Dr. Reddy's Laboratories, Inc.

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Difluprednate Ophthalmic Emulsion (CIPLA) – Container Defect (2022)

Lansoprazole Orally Disintegrating Tablets 35mg (Dr. Reddy's) – Dissolution Failure (2022)

Lansoprazole Orally Disintegrating Tablets 15mg (Dr. Reddy's) – Dissolution Failure (2022)

Propofol Injectable Emulsion (Pfizer) – Foreign Particle Contamination (2022)

Children's Botanicals Nighttime (P&G) – unapproved process (2022)

Children's Botanicals Daytime (P&G) – unapproved process (2022)

ZzzQuil Liquid Melatonin Syrup (P&G) – unapproved process (2022)

Children's Botanicals Combo (P&G) – unapproved process (2022)

ZzzQuil Pediatric Melatonin Syrup (P&G) – unapproved process (2022)

Lorazepam Injection 2mg (Hikma) – Compound Degradation (2022)

Tacrolimus Ointment (Glenmark) – Packaging Defect (2022)

Lorazepam Injection 4mg (Hikma) – Impurity Detection (2022)

Lorazepam Injection 2mg (Hikma) – Impurity Concerns (2022)

Ativan Injection (Hikma) – Compound Instability (2022)

Naftifine Hydrochloride Gel (Tolmar) – Impurity Specification (2022)

Aripiprazole Tablets 20mg (Apotex) – Dissolution Specifications (2022)

Insulin Glargine (Mylan) – Missing Medication Label (2022)

Ketamine HCl Injection (Nephron) – Sterility Risk (2022)

Lidocaine Cream (Mohnark) – child-resistant packaging (2022)

Succinylcholine Chloride Injection (Nephron) – Sterility Risk (2022)