Class II · Moderate risk Completed
Ranitidine Tablets 75 mg, a.) 30 count bottles (NDC 63868-482-30), 60 count bottles (NDC 63868-482-60) (CDMA) OTC
Reason CGMP Deviations: Presence of NDMA impurity detected in product.
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Class II · Moderate risk Completed
Ranitidine Tablets, USP 75 mg 30 count bottles (NDC 30142-131-30) (Kroger)
Reason CGMP Deviations: Presence of NDMA impurity detected in product.
Class II · Moderate risk Completed
Ranitidine Tablets, USP 75 mg, a.) 30 count bottles (NDC 69842-871-30) b.) 80 count bottles (NDC 69842-871-80) c.)160 count…
Reason CGMP Deviations: Presence of NDMA impurity detected in product.
Class II · Moderate risk Completed
Ranitidine Tablets, USP 150 mg, a.) 24 count bottles (NDC 30142-505-34), b.) 50 count bottles (NDC 30142-505-50) (Kroger) OTC
Reason CGMP Deviations: Presence of NDMA impurity detected in product.
Class II · Moderate risk Completed
Ranitidine Tablets, USP 150 mg, a.) 65 count bottles (NDC 49035-404-61) b.) 130 count bottles (NDC 49035-404-13) c.) 220 count…
Reason CGMP Deviations: Presence of NDMA impurity detected in product.
Class II · Moderate risk Completed
Ranitidine Tablets, USP 150 mg, a.) 24 count bottles (NDC 0363-0010-34), b.) 65 count bottles (NDC 0363-0010-61) , c.) 95 count…
Reason CGMP Deviations: Presence of NDMA impurity detected in product.
Class II · Moderate risk Completed
Ranitidine Tablets, USP 150 mg, 190 count bottles (2x95) Tray (Sam's Club) OTC, NDC 150062076 UPC Code 078742089720
Reason CGMP Deviations: Presence of NDMA impurity detected in product.
Class II · Moderate risk Completed
Dr. Reddy's: Ranitidine Capsules 150 mg, Rx a.) 60 count bottles (NDC 55111-129-60) b.) 500 count bottles (NDC 55111-129-05)
Reason CGMP Deviations: Presence of NDMA impurity detected in product.
Class II · Moderate risk Completed
Rite Aid Pharmacy Maximum Strength Ranitidine Tablets, USP 150 mg-acid reducer Distributed By: Rite Aid 30 Hunter Lane Camp Hill…
Reason GGMP Deviations: Possible contamination with impurity N-nitrosodimethylamine (NDMA).
Class II · Moderate risk Completed
Equate Maximum Strength Ranitidine Tablets, USP 150 mg Acid Reducer Cool Mint Tablets Sugar Free 65 Tablets NDC: 49035-117-06…
Reason GGMP Deviations: Possible contamination with impurity N-nitrosodimethylamine (NDMA).
Class II · Moderate risk Completed
Rite Aid Pharmacy Maximum Strength Ranitidine Tablets, USP 150 mg Cool Mint Acid Reducer 24 Tablets Sugar Free NDC 11822-6107-4…
Reason GGMP Deviations: Possible contamination with impurity N-nitrosodimethylamine (NDMA).
Class II · Moderate risk Completed
Equate Maximum Strength Ranitidine Tablets, USP 150 mg Acid Reducer 130 Tablets Distributed by Wal-Mart Stores, Inc. Bentonville…
Reason GGMP Deviations: Possible contamination with impurity N-nitrosodimethylamine (NDMA).
Class II · Moderate risk Completed
Walgreens Regular Strength Wal-Zan 75 Ranitidine Tablets, USP 75 mg/Acid Reducer 30 Tablets NDC 0363-1029-03 Distributed By…
Reason GGMP Deviations: Possible contamination with impurity N-nitrosodimethylamine (NDMA).
Class II · Moderate risk Completed
Walgreens Maximum Strength Wal-Zan 150 Ranitidine Tablets, USP 150 mg/Acid Reducer Distributed By: Walgreen Co., 200 Wilmot RD…
Reason GGMP Deviations: Possible contamination with impurity N-nitrosodimethylamine (NDMA).
Class II · Moderate risk Completed
Clear Eyes Redness Relief (Little Drug),Product Size: 0.2 FL. Oz., UPC#: 7-92554-70103-7
Reason Lack of Assurance of Sterility
Class II · Moderate risk Completed
Clear Eyes Redness Relief (Handy Pocket Pal), Product Size: 0.2 FL. Oz., UPC#: 6-78112-15418-7
Reason Lack of Assurance of Sterility
Class II · Moderate risk Completed
Clear Eyes Redness Relief, Product Size: 15 mL, UPC#: 6-78112-25415-6
Reason Lack of Assurance of Sterility
Class II · Moderate risk Completed
Grandall Oftal-Mycin Ophthalmic Ointment, Product Size: 3.5 g
Reason Lack of Assurance of Sterility
Class II · Moderate risk Completed
Grandall Colirio Oftal-Mycin Redness Relief Eye Drops, Product Size: 15mL
Reason Lack of Assurance of Sterility
Class II · Moderate risk Completed
FreshKote Lubricant Eye Drops, Product Size: 15 mL, NDC 15821-101-15
Reason Lack of Assurance of Sterility
Class II · Moderate risk Completed
OCuSOFT retaine NaCl Ophthalmic Ointment, Product Size: 3.5g, SKU #: 777-3-77
Reason Lack of Assurance of Sterility
Class II · Moderate risk Completed
OCuSOFT retaine NaCl Ophthalmic Ointment, Product Size: 3.5g, SKU #: 777-3-76
Reason Lack of Assurance of Sterility
Class II · Moderate risk Completed
Nano Tears XP Clear Emollient Lubricant Gel Drops twin pack, Product Size: 2 x 10 mL, Mfd. by: Altaire Pharmaceuticals, Inc…
Reason Lack of Assurance of Sterility
Class II · Moderate risk Completed
Nano Tears MXP Forte Clear Emollient Lubricant Gel Drops, Twin Pack 2 x 10 mL, Mfd. by: Altaire Pharmaceuticals, Inc…
Reason Lack of Assurance of Sterility
Class II · Moderate risk Completed
Altaire Ciprofloxacin HCl Ophthalmic Solution, 0.3%, 5 mL, NDC 59390-217-05
Reason Lack of Assurance of Sterility