Class I - Dangerous
Failed Impurities and Degradation Specifications and Subpotent Drug: out-of-specification (OOS) test results for below assay and above specification for degradants.
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Prescription Drugs
💊 Drugs • 11,927 recalls
Potassium Chloride For Injection Concentrate syringe 40 mEq/20 mL (2 mEq/mL), Rx only, Medi-Fare Drug Pharmaceutical Compounding 300 West Pine St., Blacksburg, SC 29702 800-622-0007
Medi-Fare Drug and Home Health Center
Class I - Dangerous
CGMP Deviations: Syringes were filled with 19mL of potassium chloride when the labels displayed a fill of 20mL.
Neostigmine Methylsulfate Injection Solution, 5 mg per 5 mL, 1 mg per mL, 5 mL prefilled syringe, 5 syringes per package, Rx only, Fagron Sterile Services, ICB Laboratories, 8710 E 34th St. N., Wichita, KS 67205, NDC 71266-2003-02.
Fagron Compounding Services LLC
Class I - Dangerous
Labeling: Label Error on Declared Strength: syringes of Neostigmine Methylsulfate 1 mg per mL, 5 mg per 5 mL may be incorrectly labeled as Neostigmine Methylsulfate 1 mg per mL, 3 mg per 3 mL.
Class I - Dangerous
Labeling: Incorrect or Missing Lot and/or Exp Date.
Class I - Dangerous
Superpotent Drug: High out of specification assay value results for potency.
Neostigmine Methylsulfate Injection Solution, 3 mg per 3 mL, 1 mg per mL, 3 mL prefilled syringe, 5 syringes per package, Rx only, Fagron Sterile Services, ICB Laboratories, 8710 E 34th St. N., Wichita, KS 67205, NDC 71266-2003-01.
Fagron Compounding Services LLC
Class I - Dangerous
Labeling: Label Error on Declared Strength: syringes of Neostigmine Methylsulfate 1 mg per mL, 5 mg per 5 mL may be incorrectly labeled as Neostigmine Methylsulfate 1 mg per mL, 3 mg per 3 mL.
Class I - Dangerous
Labeling: Incorrect or Missing Lot and/or Exp Date.
Class I - Dangerous
Superpotent Drug: High out of specification assay value results for potency.
Class I - Dangerous
Subpotent Drug: final drug concentration is subpotent as compared to the concentration indicated on the label.
Atorvastatin Calcium Tablets, 40 mg*, packaged as a) 90-count bottle (NDC 55111-123-90 and b) 500-count bottle (NDC 55111-123-05), Rx Only, Mfd. By: Dr. Reddy's Laboratories Limited, Srikakulam - 532 409 INDIA
Dr. Reddy's Laboratories
Class I - Dangerous
Failed Impurities/Degradation Specifications
Atorvastatin Calcium Tablets, 20 mg*, 90-count bottle, Rx Only, Mfd. By: Dr. Reddy's Laboratories Limited, Srikakulam - 532 409 INDIA, NDC 55111-122-90
Dr. Reddy's Laboratories
Class I - Dangerous
Failed Impurities/Degradation Specifications
Class I - Dangerous
Lack of assurance of sterility: Bags have potential to leak.
Atorvastatin Calcium Tablets, 80 mg*, 90-count bottles, Rx Only, Mfd. By: Dr. Reddy's Laboratories Limited, Srikakulam - 532 409 INDIA, NDC 55111-124-90 UPC 355111124900
Dr. Reddy's Laboratories
Class I - Dangerous
Presence of Foreign Substance: A product complaint was received for a defective tablet with an embedded foreign object observed in a bottle.
5% Dextrose Injection, USP, 250 mL bag, Rx Only, Hospira, Inc. Lake Forest, IL 60045, NDC 0409-7922-02
ICU Medical
Class I - Dangerous
Lack of assurance of sterility: Bags have potential to leak.
Atorvastatin Calcium Tablets, 10 mg*, 90-count bottle, Rx Only, Mfd. By: Dr. Reddy's Laboratories Limited, Srikakulam - 532 409 INDIA, NDC 55111-121-90
Dr. Reddy's Laboratories
Class I - Dangerous
Failed Impurities/Degradation Specifications
Class I - Dangerous
Lack of assurance of sterility: Bags have potential to leak.
Class I - Dangerous
Lack of assurance of sterility: Bags have potential to leak.
Class I - Dangerous
Lack of assurance of sterility: Bags have potential to leak.
Maxzide-25 (Triamterene and hydrochlorothiazide) tablets, USP, 37.5 mg/ 25 mg, 100-count bottle, Rx only, Mylan Pharmaceuticals Inc., Morgantown, WV 26505, NDC 0378-0464-01
Mylan Pharmaceuticals
Class I - Dangerous
Superpotent Drug: Composite assay results obtained during routine stability testing were slightly above specification.
Class I - Dangerous
Contraceptive Tablets Out of Sequence.