Class I - Dangerous
Failed Excipient Specifications; product manufactured using an excipient found to be OOS for conductivity
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Drugs Recalls
Prescription and over-the-counter medications
17,302 Total Recalls
Class I - Dangerous
Failed Excipient Specifications and Presence of Foreign Tablets/Capsules; product manufactured using an excipient found to be OOS for conductivity and some Ezetimibe and Simvastatin Tablets, 10 mg/10 mg were found in the bottle
Class I - Dangerous
Failed Excipient Specifications; product manufactured using an excipient found to be OOS for conductivity
Class I - Dangerous
Presence of Particulate Matter: Identified as Glass Particles
Methocarbamol 500mg Tablet, packaged in a) #30 count (NDC 7133517952), b) #60 count (NDC 7133517954), and c) #90 count (NDC 7133517957) bottles, Rx only, Prinston Laboratories, Packaged by Bryant Ranch Prepack Burbank, CA 91504
Bryant Ranch Prepack, Inc.
Class I - Dangerous
Labeling: Label Error on Declared Strength; Bottles labeled as Methocarbamol 500 mg Tablets actually contain Methocarbamol 750 mg Tablets
Irbesartan and Hydrochlorothiazide Tablets USP, 150/12.5 mg a) 30 count (NDC 68180-413-06) and b) 90 count (NDC 68180-413-09) bottles, Rx only
Lupin Pharmaceuticals
Class I - Dangerous
CGMP Deviations: impurity N-nitrosoirbesartan detected in API
Class I - Dangerous
Out-of-specification test results obtained in Organic Impurities test during analysis of controlled samples.
PYRIDOXINE HCL (B6) 100MG/ML MDV, Red Mountain Compounding Rx
First Royal Care Co. LLC
Class I - Dangerous
Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns
Class I - Dangerous
Out-of-specification test results obtained in Organic Impurities test during analysis of controlled samples.
Failed Stability Specifications: Out-of-Specification results observed for Aspirin related compound Salicylic Acid.
METHYLCOBALAMIN 10,000MCG/ML MDV INJ, Rx only, Red Mountain Compounding Rx
First Royal Care Co. LLC
Class I - Dangerous
Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns
TEST CYP 50MG/ML IN ETHYL OLEATE OIL, Rx only, Red Mountain Compounding Rx
First Royal Care Co. LLC
Class I - Dangerous
Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns
DEXPANTHENOL 250MG/ML INJ SOLN, Rx only, Red Mountain Compounding Rx
First Royal Care Co. LLC
Class I - Dangerous
Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns
TEST CYP 200MG/ML IN SESAME OIL MDV, Rx only, Red Mountain Compounding Rx
First Royal Care Co. LLC
Class I - Dangerous
Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns
Class I - Dangerous
Failed Stability Specifications: Out-of-Specification results observed for Aspirin related compound Salicylic Acid.
AllerClear D-24 hr, (Loratadine and Pseudoephedrine Sulfate, Extended-Release Tablets, USP 10/240mg), 15-count blister packs, Manufactured by: Ohm Laboratories Inc., 1385 Livingston Avenue, North Brunswick, NJ 08902, NDC 63981-724-15
SUN PHARMACEUTICAL INDUSTRIES
Class I - Dangerous
Failed Moisture Limits
ESTRADIOL VALERATE 5MG/ML MDV INJ, Rx only, Red Mountain Compounding Rx
First Royal Care Co. LLC
Class I - Dangerous
Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns
TESTOSTERONE ULTRA 250MG/ML MDV IN SESAME OIL, Rx only, Red Mountain Compounding Rx
First Royal Care Co. LLC
Class I - Dangerous
Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns
CYCLOSPORINE 2% MCT OIL SUSP, Rx only, Red Mountain Compounding Rx
First Royal Care Co. LLC
Class I - Dangerous
Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns
ASCORBIC ACID (NON-CORN) 500MG/ML MDV SOLN, Rx only, Red Mountain Compounding Rx
First Royal Care Co. LLC
Class I - Dangerous
Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns