Class I - Dangerous
SubPotent Drug: Low out-of-specification results for assay testing.
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Prescription Drugs
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Ibuprofen 50 mg per 1.25 mL Oral Suspension Advil Infant Concentrated Drops White Grape 0.75 oz. and 1 oz. bottles NDC 0573-0191-75 (0.75 oz.) NDC 0573-0191-50 (1 oz.)
Glaxosmithkline Consumer Healthcare Holdings
Class I - Dangerous
Labeling: Lacks Warning or Rx Legend- Certain lots does not include required safety warning information in the Drug Facts Panel.
Class I - Dangerous
CGMP Deviation; Possible contamination with impurity N-nitrosodimethylamine.
PrediniSONE Tablets, USP 5 mg, 48-count bottle, Rx only, Distributed by: Par Pharmaceutical Chestnut Ridge, NY 10977, NDC 0603-5337-31
Par Pharmaceutical
Class I - Dangerous
Labeling: Incorrect or Missing Exp Date - An incorrect expiration date has been identified on Prednisone Tablets USP 5 mg
CGMP Deviation; Possible contamination with impurity N-nitrosodimethylamine.
Sotalol HCL Tablets, USP (AF) 80 mg, 100 count bottles, Rx Only, Mylan Pharmaceuticals Inc. Morgantown, WV 26505 USA. NDC 00378-5123-01
Mylan Pharmaceuticals
Class I - Dangerous
Presence of particulate matter. presence of metal particles.
Class I - Dangerous
Marketed without an Approved NDA/ANDA: Product contains undeclared sildenafil which was discovered through FDA analysis.
CGMP Deviation; Possible contamination with impurity N-nitrosodimethylamine.
Class I - Dangerous
Defective Delivery System: Out of specification for mechanical peel and shear.
Maximum Strength Acid Reducer, Cool Mint Ranitidine tablets, USP 150 mg, 95 tablets per bottle. [Brand, NDC] NDC Basic Care: 0113-7950-01; NDC CVS Health: 59779-950-01
Perrigo Company PLC
Class I - Dangerous
CGMP Deviation; Possible contamination with impurity N-nitrosodimethylamine.
CGMP Deviation; Possible contamination with impurity N-nitrosodimethylamine.
Sodium Chloride 0.9% Injection, USP, 1000 mL bags, Rx only, Manufactured by: Fresenius Medical Care North America, Waltham, MA 02451
Fresenius Medical Care Holdings
Class I - Dangerous
CGMP Deviation: Chemical indicators were not positioned properly during sterilization process.
Doxycycline Capsules, USP, 75 mg, 100-count bottle, Rx only, Manufactured by: Ohm Laboratories Inc., New Brunswick, NJ 08901; Distributed by Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512; NDC 63304-615-01.
Sun Pharmaceutical Industries
Class I - Dangerous
CGMP Deviations: Doxycycline capsules were not manufactured under Current Good Manufacturing Practice conditions.
Regular Strength Acid Reducer, Ranitidine tablets, USP 75 mg, 160 tablets per bottle. [NDC: Brand] NDC CVS Health.: 69842-293-06
Perrigo Company PLC
Class I - Dangerous
CGMP Deviation; Possible contamination with impurity N-nitrosodimethylamine.
Class I - Dangerous
Presence of Foreign Tablets/Capsules: This is a spin-off recall of D-1581-2019 due to a product complaint where one of Lupin's Fenofibrate 145mg was observed in the 500 s count product bottle.
Maximum Strength Acid Reducer, Ranitidine tablets, USP 150 mg, 90 tablets per bottle. [Brand, NDC] NDC Equate: 49035-608-75; NDC Up & Up: 11673-023-75
Perrigo Company PLC
Class I - Dangerous
CGMP Deviation; Possible contamination with impurity N-nitrosodimethylamine.
Maximum Strength Acid Reducer, Cool Mint Ranitidine tablets, USP 150 mg, 40 tablets per bottle. [Brand, NDC] NDC Up & Up: 11673-950-58
Perrigo Company PLC
Class I - Dangerous
CGMP Deviation; Possible contamination with impurity N-nitrosodimethylamine.
Class I - Dangerous
CGMP Deviation; Possible contamination with impurity N-nitrosodimethylamine.
CGMP Deviation; Possible contamination with impurity N-nitrosodimethylamine.
Potassium Chloride Extended-Release Tablets USP, 10mEq (750mg), 1000-count bottle, Rx only, Manufactured by: Strides Shasun Limited Bengaluru - 562106, India, Distributed by: Strides Pharma Inc., East Brunswick, NJ 08816, NDC 64380-861-08
Strides Pharma Science Limited
Class I - Dangerous
Failed Tablet/Capsules Specifications: Oversized tablets were found in one lot of Potassium Chloride Tablets 750 mg.