Alcohol Prep Pads (Isopropyl Alcohol USP 70% v/v), 100 Individual Pads, Sterile, Distributed by Simple Diagnostics, Winston Park, NY NDC 98302-0001-05
Simple Diagnostics
Class I - Dangerous
Lack of Assurance of Sterility and cGMP Deviations
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Drugs Recalls
Prescription and over-the-counter medications
17,685 Total Recalls
Auryxia (ferric citrate) tablets, 210 mg , 200-count bottles, RX ONLY, Manufactured for and distributed by: Keryx Biopharmaceticals, Inc. One Marina Park Drive, 12th Floor, Boston, MA 02210 USA. NDC 59922-631-01
Keryx Biopharmaceuticals
Class I - Dangerous
Presence of Foreign Substance: Reports have been received of damaged StripPax packets containing silica gel desiccant potentially allowing the silica gel granules to make contact with Auryxia tablets in the bottle.
Fentanyl 2 mcg/mL and ropivacaine 0.2% in 0.9% Sodium Chloride 150 mL, 150 mL bag, This is a compounded injectable drug; Rx only; Hospital/office use only. SSM St. Clare Outsourcing Facility, Fenton, MO. --- NDC: 88883-4272-01
SSM Health Care St. Louis
Class I - Dangerous
Lack of sterility assurance: Microbial growth detected during a routine simulation of the manufacturing process. No batches of distributed product have been identified as actually containing microorganisms.
Class I - Dangerous
Labeling: Incorrect or Missing Lot and/or Exp. Date
Class I - Dangerous
Lack of sterility assurance: Microbial growth detected during a routine simulation of the manufacturing process. No batches of distributed product have been identified as actually containing microorganisms.
LaBri's Body Health Atomic 60 Capsules Exclusively distributed worldwide by LaBri's Body Health.
EZWeightLossTX
Class I - Dangerous
Marketed Without An Approved NDA/ANDA: Tainted Product Marketed As a Dietary Supplements: products found to be tainted with sibutramine making these unapproved drugs.
LaBri's Body Health XPLODE 30 capsules Exclusively distribute worldwide by LaBri's Body Health.
EZWeightLossTX
Class I - Dangerous
Marketed Without An Approved NDA/ANDA: Tainted Product Marketed As a Dietary Supplements: products found to be tainted with sibutramine making these unapproved drugs.
Class I - Dangerous
Presence of Particulate Matter: glass particulate found in vial
0.25% Acetic Acid Irrigation USP, 500 mL Plastic Irrigation Container (PIC), B. Braun Medical Inc. Irvine CA 92614-5895 USA, NDC 0264-2304-10
B. Braun Medical
Class I - Dangerous
Presence of Particulate Matter: identified as polyethylene, which is consistent with the material used to manufacture the contain cap
Class I - Dangerous
Stability Data Does Not Support Expiry: lots do not have stability that supports the use of the container system.
Methylphenidate Hydrochloride Extended-release Tablets, USP 27 mg, 100-count bottles, Rx Only, Trigen Laboratories, LLC. Bridgewater, NJ 08807, NDC 13811-707-10
Osmotica Pharmaceutical
Class I - Dangerous
Subpotent Drug
Class I - Dangerous
Subpotent Drug: found to be below the specification for labeled assay.
Class I - Dangerous
Stability Date Doesn't Support Expiry: labeling error indicating a beyond use date that exceeds current stability data.
Class I - Dangerous
Superpotent
Class I - Dangerous
Stability Data Does Not Support Expiry: lots do not have stability that supports the use of the container system.
Class I - Dangerous
Stability Data Does Not Support Expiry: lots do not have stability that supports the use of the container system.
Class I - Dangerous
Subpotent Drug: found to be below the specification for labeled assay.
Class I - Dangerous
Superpotent
Class I - Dangerous
Stability Data Does Not Support Expiry: lots do not have stability that supports the use of the container system.
Class I - Dangerous
Labeling: Incorrect Instructions. "TABLETS IN WEEK 4 ARE INACTIVE" printed on the blister foil and package insert, however,all tablets are active.