Class I - Dangerous
Labeling: Missing Label
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Prescription Drugs
💊 Drugs • 12,141 recalls
Loxapine Capsules, USP 50 mg, packaged in 100 Unit Dose capsules, Rx only, Manufactured by Mylan Pharmaceuticals Inc. Morgantown, WV 26505 U.S.A. NDC 51079-903-20.
Mylan Institutional, Inc. (d.b.a. UDL Laboratories)
Class I - Dangerous
GMP Deviations: a recent FDA inspection of the manufacturing site revealed multiple cGMP violations that would place Loxapine at risk for cross contamination
Class I - Dangerous
Marketed Without An Approved NDA/ANDA: FDA analysis found the product to contain undeclared tadalafil. The presence of tadalafil makes Rhino Extreme 50000 an unapproved drug for which safety and efficacy have not been established and, therefore, subject to recall.
Class I - Dangerous
Marketed Without an Approved NDA/ANDA: 2-pack configuration did not receive appropriate regulatory approval prior to release.
Class I - Dangerous
Marketed Without an Approved NDA/ANDA: 2-pack configuration did not receive appropriate regulatory approval prior to release.
PrednisoLONE Sodium Phosphate Orally Disintegrating Tablets 15 mg, Rx Only, 48-count bottle, NDC 00378-4715-22
Mylan Pharmaceuticals
Class I - Dangerous
CGMP Deviations
Loxapine Capsules, USP 50 mg, Rx Only, 100-count bottles, NDC 0378-7050-01
Mylan Pharmaceuticals
Class I - Dangerous
CGMP Deviations
0.9% Sodium Chloride Injection, USP, 1000 mL, Rx Only, Fresenius Medical Care North America, Waltham, MA 02451, NDC 49230-0300-10.
Fresenius Medical Care Renal Therapies Group
Class I - Dangerous
Lack of Assurance of Sterility
Class I - Dangerous
Labeling: Label Mix-Up: bottle labeled as Diclofenac Sodium and Misoprostol 75 mg/0.2 mg contained Diclofenac Sodium and Misoprostol 50 mg/0.2 mg tablets.
PrednisoLONE Sodium Phosphate Orally Disintegrating Tablets 10 mg, Rx Only, 48-count bottle, NDC 00378-4710-22
Mylan Pharmaceuticals
Class I - Dangerous
CGMP Deviations
PrednisoLONE Sodium Phosphate Orally Disintegrating Tablets, 30 mg, Rx Only, 48-count bottle, NDC 00378-4730-22
Mylan Pharmaceuticals
Class I - Dangerous
CGMP Deviations
Loxapine Capsules, USP 25 mg, packaged in 100 Unit Dose Capsules, Rx only, Manufactured by Mylan Pharmaceuticals Inc. Morgantown, WV 26505 U.S.A. NDC 51079-902-20
Mylan Institutional, Inc. (d.b.a. UDL Laboratories)
Class I - Dangerous
GMP Deviations: a recent FDA inspection of the manufacturing site revealed multiple cGMP violations that would place Loxapine at risk for cross contamination
Loxapine Capsules, USP 25 mg, Rx Only, 100-count bottles, NDC 0378-7025-01
Mylan Pharmaceuticals
Class I - Dangerous
CGMP Deviations
Class I - Dangerous
Failed Stability Specifications
Class I - Dangerous
Subpotent Drug: High Levels of Impurities Resulting in Decrease Potency
Class I - Dangerous
Labeling: Not Elsewhere Classified: due to a labeled declaration of; Store at 15¿C to 30¿C (59¿F to 86¿F) which differs from the original manufacturer declaration of; Store at 20¿C to 25¿C (68¿F to 77¿F).
Class I - Dangerous
Labeling: Not Elsewhere Classified: due to a labeled declaration of; Store at 15¿C to 30¿C (59¿F to 86¿F) which differs from the original manufacturer declaration of; Store at 20¿C to 25¿C (68¿F to 77¿F).
Class I - Dangerous
Subpotent Drug: High Levels of Impurities Resulting in Decrease Potency
Ferrous Sulfate 325 MG tablet; NDC 33261-0715-00
Aidarex Pharmaceuticals
Class I - Dangerous
Presence of Foreign Tablets/Capsules
Amlodipine and Benazapril HCL Capsules, USP, 5 mg/40 mg, 100 count bottles, Mylan Pharmaceuticals, Inc., Morgantown, WV --- NDC 0378-6899-01
Mylan Pharmaceuticals
Class I - Dangerous
cGMP Deviations; cleaning processes for equipment used to manufacture the specified batches was not followed according to procedure