Class I - Dangerous
Labeling: Label mix-up. Finished product Povidone iodine 7.5% was labeled as Povidone iodine 10% , the outer box had the correct label.
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Drugs Recalls
Prescription and over-the-counter medications
17,685 Total Recalls
Latanoprost PF Solution, 0.005%, Ophthalmic Drops in Sterile 5ml Bottles, Compounded for a licensed professional or patient use, imprimisRx, Irvine, CA
ImprimisRx CA, Inc.
Class I - Dangerous
Incorrect/Undeclared Excipient; non-pharmaceutical grade PEG 40 Castor Oil was used due to a mislabeling by the supplier
Timolol-Latanoprost PF Solution (0.5-0.005)%, Ophthalmic Drops, Sterile 5ml Bottle, Compounded for a licensed professional or patient use, imprimisRx, Irvine, CA
ImprimisRx CA, Inc.
Class I - Dangerous
Incorrect/Undeclared Excipient; non-pharmaceutical grade PEG 40 Castor Oil was used due to a mislabeling by the supplier
Timolol-Brimonidine-Dorzolamide-Latanoprost (0.5/0.15/2/0.005)% Ophthalmic Drops, Sterile 5ml Bottle, Compounded for a licensed professional or patient use, imprimisRx, Irvine, CA
ImprimisRx CA, Inc.
Class I - Dangerous
Incorrect/Undeclared Excipient; non-pharmaceutical grade PEG 40 Castor Oil was used due to a mislabeling by the supplier
Curcumin Emulsion 10mg/ml Injection, Sterile 10 mL Multiple Dose Vial, For Slow IV Administration, Compounded for a licensed professional or patient use by ImprimisRx, Irvine, CA
ImprimisRx CA, Inc.
Class I - Dangerous
Incorrect/Undeclared Excipient; non-pharmaceutical grade PEG 40 Castor Oil was used due to a mislabeling by the supplier
Propafenone Hydrochloride tablets, 150 mg, packaged in 10 x 10 unit dose cards (100-count box), Rx only, Manufactured By: Watson Pharmaceuticals 311 Bonnie Circle Corona, CA 92880, NDC 63739-509-10
Mckesson Packaging Services
Class I - Dangerous
Failed moisture limits: Out of specification for moisture content.
Class I - Dangerous
Defective container: Oral solution leaking from container.
Class I - Dangerous
Presence of Foreign Substance: customer complaint of blue foreign material identified as a portion of a nitrile glove was discovered in product.
Ketorolac Tromethamine Injection, USP 30 mg/mL, packaged in 1 mL single-dose vials, Rx only, Amphastar Pharmaceuticals, Inc., Rancho Cucamonga, CA 91730, NDC 0548-9021-00
Amphastar Pharmaceuticals
Class I - Dangerous
Crystallization: Particulate matter (Ketorolac Calcium Salt) was observed from several lots of retained samples.
Rugby Diocto Syrup, Docusate Sodium 60 mg/15 mL, Stool Softener Laxative, One Pint (473 mL) plastic bottles, Dist. by: Rugby Laboratories, 31778 Enterprise Drive, Livonia, MI 48150. NDC: 0536-1001-85
The Harvard Drug Group
Class I - Dangerous
Microbial contamination of Non-sterile Products; presence of yeast and potential B. cepacia contamination
Class I - Dangerous
Labeling: Label Mixup; potentially mislabeled
Class I - Dangerous
Microbial contamination of Non-sterile Products; presence of yeast and potential B. cepacia contamination
Class I - Dangerous
Microbial contamination of Non-sterile Products; presence of yeast and potential B. cepacia contamination
Class I - Dangerous
Failed Impurities/Degradation Specifications:Out of specification results for individual unknown impurities at 30th month Room Temperature Retained Sample stabilities test .
Class I - Dangerous
Microbial contamination of Non-sterile Products; presence of yeast and potential B. cepacia contamination
Class I - Dangerous
Microbial contamination of Non-sterile Products; presence of yeast and potential B. cepacia contamination
Class I - Dangerous
Labeling: Labeled Error on Declared Strength; report of a 1000 ct bottle labeled as Phenobarbital 15 mg tablets actually contained 30 mg tablets
Class I - Dangerous
Labeling: Label Mixup; potentially mislabeled
Class I - Dangerous
Labeling: Label Mixup; potentially mislabeled
Class I - Dangerous
Labeling: Label Mixup; potentially mislabeled