Class I - Dangerous
Failed Dissolution Specifications
💊
Prescription Drugs
💊 Drugs • 12,141 recalls
Aripiprazole Tablets USP, Rx only, 30 mg, 30 tablets, Marketed by: Ajanta Pharma USA Inc., Bridgewater, NJ 08807, Made in India, NDC 27241-056-03.
Ajanta Pharma USA
Class I - Dangerous
Product Mix-Up: A bottle containing Voriconazole Tablets 50 mg was labelled and distributed as Aripiprazole Tablets USP 30 mg.
Class I - Dangerous
Labeling: Incorrect or Missing Lot and/or Exp Date
Class I - Dangerous
Failed Impurities/Degradation Specifications: This recall is being initiated due to out-of-specification results total impurities.
Class I - Dangerous
Crystallization; identified as Buprenorphine free base
Class I - Dangerous
Failed Dissolution Specifications: An out-of-specification (OOS) result was observed during the 9th month of dissolution test analysis
Class I - Dangerous
CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit
Epinephrine Injection, USP, 1mg/mL, 1 mL single-dose vial, Rx only, Fresenius Kabi, Lake Zurich, IL 60047, NDC 63323-696-02 (vial), NDC 63323-696-25 (carton)
Fresenius Kabi USA
Class I - Dangerous
Failed Impurities/Degradations Specifications
Class I - Dangerous
Presence of Particulate matter: Particulate matter identified as glass.
Class I - Dangerous
CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit
Class I - Dangerous
Cross Contamination with Other Products: due to a potential for cross-contamination with Acemetacin API due to an issue at the API manufacturer.
Class I - Dangerous
Failed Dissolution Specifications: During 12-month long-term stability testing, subject lot was out of specification (low) for stage 3 dissolution at the 24-hour timepoint.
HALEON CALCIUM CARBONATE TUMS ANTACID, Assorted Fruit Tablets, 1000 mg, 160-count bottle, Haleon, Warren, NJ 07059, UPC 3 07660 74610 2.
Guardian Drug Co.
Class I - Dangerous
Presence of foreign substance: small metallic particles in chewable tablets.
Lidocaine HCl Injection USP, 25x5 mL, Single-Dose Ampules, Rx Only, Distributed by: Spectra Medical Devices, LLC, Wilmington, Made in S. Korea, NDC 65282-1605-1.
Spectra Medical Devices
Class I - Dangerous
Lack of Assurance of Sterility
HyVee, Ultra Strength Antacid, Calcium Carbonate 1000 mg, 72 CHEWABLE TABLETS, DISTRIBUTED BY: HY-VEE INC., Inc., WEST DES MOINES, IA 50266, UPC: 0 75450 82514 5.
Guardian Drug Co.
Class I - Dangerous
Presence of foreign substance: small metallic particles in chewable tablets.
CAREone, EXTRA STRENGTH CALCIUM ANTACID, Calcium Carbonate 750 mg, 96 chewable Tablets, Distributed by: FOODHOLD U.S.A, LLC, LANDOVER, MD 20785, NDC 72476-127-80.
Guardian Drug Co.
Class I - Dangerous
Presence of foreign substance: small metallic particles in chewable tablets.
HyVee, Extra Strength Antacid, Calcium Carbonate 750 mg, 96 CHEWABLE TABLETS, DISTRIBUTED BY: HY-VEE INC., Inc., WEST DES MOINES, IA 50266, UPC: 0 75450 82497 1.
Guardian Drug Co.
Class I - Dangerous
Presence of foreign substance: small metallic particles in chewable tablets.
Class I - Dangerous
Labeling: Not Elsewhere Classified: The label wrap covers the barcode, making it hard to scan
Class I - Dangerous
Presence of foreign substance: small metallic particles in chewable tablets.
Class I - Dangerous
Presence of foreign substance: small metallic particles in chewable tablets.