Class I - Dangerous
Penicillin Cross Contamination and Presence of Foreign Substance. Product was contaminated with penicillin and foreign substances during manufacturing process.
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Prescription Drugs
💊 Drugs • 12,141 recalls
Class I - Dangerous
Presence of Particulate Matter: Customer complaint for an insect found free floating inside a single bag for each lot recalled.
Class I - Dangerous
Presence of Particulate Matter
Class I - Dangerous
Presence of Particulate Matter
Class I - Dangerous
Lack of Assurance of Sterility: Failed preservative effectiveness testing.
Class I - Dangerous
Failed Dissolution Testing: Failed 24 month dissolution testing.
Class I - Dangerous
Failed Dissolution Specification: During analysis of the 18 month long term stability testing, it was noticed that the drug release results at the 4 hour time point are not meeting specifications.
AMPICILLIN CAPSULES, USP, 250 mg, 500 count bottles, Rx only, Manufactured for: DAVA Pharmaceuticals, Inc., Fort Lee, NJ, By: Suir Pharma Ireland Ltd., Clonmel, Ireland, NDC: 67253-180-50
Vintage Pharmaceuticals LLC
Class I - Dangerous
Labeling: Incorrect Or Missing Package Insert: Product is labeled with unapproved labeling.
Class I - Dangerous
Presence of Particulate Matter
Class I - Dangerous
Presence of Particulate Matter
Class I - Dangerous
CGMP Deviations: An FDA inspection identified inadequate investigations of past market complaints.
Class I - Dangerous
CGMP Deviations: An FDA inspection identified inadequate investigations of past market complaints.
Class I - Dangerous
Presence of Particulate Matter: Customer complaint for an insect found free floating inside a single bag for each lot recalled.
PYROLA Advanced Joint Formula capsules, 60-count bottle, G & C Natural Nutrition Inc., Fullerton, CA 92833, UPC 7 11746 00075 8.
GC Natural Nutrition
Class I - Dangerous
Marketed Without An Approved NDA/ANDA: Product was found to contain undeclared diclofenac, a prescription non-steroidal anti-inflammatory drug, and chlorpheniramine, an over-the-counter antihistimine, making this an unapproved drug.
Class I - Dangerous
Incorrect Expiration Date: The "11/06" expiration date printed on the tray (secondary packaging) is incorrect (it should be 11/2016)
Class I - Dangerous
Presence of Particulate Matter
0.9% Sodium Chloride Injection USP, 500 mL in VIAFLEX Plastic Container, Baxter Healthcare Corporation Deerfield, IL 60015, NDC 0338-0049-03.
Baxter Healthcare
Class I - Dangerous
Presence of Particulate Matter and Lack of Assurance of Sterility: The firm received a complaint for customer of presence of particulate matter, leaky containers, and missing port protectors.
Class I - Dangerous
Presence of Particulate Matter
Rivastigmine Tartrate Capsules, USP 1.5 mg, 60 count bottle, Rx Only, Mfd. By Dr. Reddy's Laboratories Limited, Bachupally, India, NDC 55111-352-60
Dr. Reddy's Laboratories
Class I - Dangerous
Failed Dissolution Specifications
SO-Acetylcysteine 10% Sterile Ophthalmic Solution, Rx Only, 10 mL bottle, Apothecary Shoppe, Compounding Pharmacy, Tulsa, OK 74135, NDC 13452-2774-94
The Apothecary Shoppe
Class I - Dangerous
Lack of Assurance of Sterility: Due to lack of documentation of proper environmental monitoring during the time in which the medication was produced.