Class I - Dangerous
Subpotent drug
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Drugs Recalls
Prescription and over-the-counter medications
17,685 Total Recalls
Duloxetine Delayed-Release Capsules USP, 60mg, Rx Only, 90-count bottle, Mfr. by Towa Pharmaceutical Eurpoe S.L., Martorelles, (Barcelona), Spain, Dist. by. Breckenridge Pharmaceutical, Inc., Berkely Heights, NJ 07922, NDC 51991-748-90.
Breckenridge Pharmaceutical
Class I - Dangerous
CGMP Deviations; presence of N-nitroso-duloxetine impurity above the FDA recommended limit
Lactated Ringer's Injection USP, 1000 mL container, Rx only, B. Braun Medical, Inc., Bethlehem, PA 18018-3524 USA, NDC 0264-7750-07.
B BRAUN MEDICAL
Class I - Dangerous
Presence of Particulate Matter.
DELFLEX, Dextrose Peritoneal Dialysis Solution with attached stay-safe Exchange Set for Intraperitoneal Dialysis Only, 2.5% DEX. LM/LC, 2L 5PK, Part Number 054-20222, Fresenius Medical Care North America, 920 Winter Street, Waltham, MA 02451.
Fresenius Medical Care Holdings
Class I - Dangerous
Lack of Assurance of Sterility: Potential leaks from perforations in bags.
Lack of Assurance of Sterility: Quality system deficiencies identified during a routine U.S Food and Drug Administration (FDA) inspection at the contract manufacturer.
DELFLEX, Dextrose Peritoneal Dialysis Solution with attached stay-safe Exchange Set for Intraperitoneal Dialysis Only, 1.5% DEX. LM/LC, 2L 5PK, Part Number 054-20221, Fresenius Medical Care North America, 920 Winter Street, Waltham, MA 02451.
Fresenius Medical Care Holdings
Class I - Dangerous
Lack of Assurance of Sterility: Potential leaks from perforations in bags.
Class I - Dangerous
CGMP Deviations: Presence of N-nitroso-Duloxetine impurity above FDA recommended limit of 0.83 ppm, identified at the 12-month and 18-month long-term stability intervals.
Class I - Dangerous
Lack of Assurance of Sterility: This recall has been initiated due to CGMP deviations found by the FDA during an inspection of the manufacturer.
Ketamine Hydrochloride Injectable Solution, 50mg/ml, (50 mg per mL) Volume: 1 mL, 5265 Kitty Drive, Houston, TX 77054, NDC 73702-302-31.
Wells Pharma of Houston
Class I - Dangerous
cGMP deviations.
Class I - Dangerous
Lack of Assurance of Sterility: This recall has been initiated due to CGMP deviations found by the FDA during an inspection of the manufacturer.
fentaNYL Citrate Injectable Solution in 0.9% Sodium Chloride, 1000 mcg/50mL (20 mcg per mL), well pharma of Houston, NDC 73702-203-65.
Wells Pharma of Houston
Class I - Dangerous
cGMP deviations.
fentaNYL Citrate injectable Solution in 0.9% Sodium Chloride, Narcotic, (2500 mcg/ 250 mL) (10 mcg per mL), 250 mL bag, wells pharma of Houston, NDC 73702-202-03.
Wells Pharma of Houston
Class I - Dangerous
cGMP deviations.
Class I - Dangerous
Lack of Assurance of Sterility: Due to FDA inspection observations that it believes may impact product quality.
Alendronate Sodium Oral Solution, 70 mg/75 mL, 75 mL, Rx only, 4 x 75 mL Single Dose Bottles, Distr. by: Hikma Pharmaceuticals USA Inc., Berkeley Heights, NJ 07922, NDC 0054-0282-59.
Hikma Pharmaceuticals USA
Class I - Dangerous
This recall is being conducted due to out of specification assay results in a limited number of bottles that were stored on side.
fentaNYL Citrate Injectable Solution, NARCOTIC, Cii, 1000 mcg/100 mL (10 mcg per mL), 100 mL bag, Wells Pharma in Houston, NDC 73702-202-02.
Wells Pharma of Houston
Class I - Dangerous
cGMP deviations.
Class I - Dangerous
Lack of Assurance of Sterility
fentaNYL Citrate Injectable Solution, Narcotic, CII, 1250 mcg/25mL (50 mcg per mL), 25 mL, wells pharma of Houston, NDC 73702-204-25.
Wells Pharma of Houston
Class I - Dangerous
cGMP deviations.
Lidocaine Wound Gel (Benzalkonium Chloride, 0.13% and Lidocaine Hydrochloride, 2%), NET WT 0.5 OZ (14 g), Distributed by: CVS PHarmacy, INc., One CVS Drive, Woonsocket, RI 02895. NDC 59898-950
Water-Jel Technologies
Class I - Dangerous
Failed PH Specifications
Class I - Dangerous
Lack of Assurance of Sterility: Due to FDA inspection observations that it believes may impact product quality.
Phenylephrine Hydrochloride Injectable Solution, 40mg, 250*mL Bag, wells pharma of Houston, NDC 73702-122-03
Wells Pharma of Houston
Class I - Dangerous
cGMP deviations.