Labeling: Incorrect or Missing Lot and/or Exp. Date
Prescription Drugs
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Labeling: Incorrect or Missing Lot and/or Exp. Date
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.
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.
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
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
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.
Labeling: Incorrect or Missing Lot and/or Exp. Date
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
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
Marketed Without An Approved NDA/ANDA: Tainted Product Marketed As a Dietary Supplements: products found to be tainted with sibutramine making these unapproved drugs.
Presence of Particulate Matter: glass particulate found in vial
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
Subpotent Drug
Subpotent Drug: found to be below the specification for labeled assay.
Superpotent
Stability Data Does Not Support Expiry: lots do not have stability that supports the use of the container system.
Stability Data Does Not Support Expiry: lots do not have stability that supports the use of the container system.
Subpotent Drug: found to be below the specification for labeled assay.
Superpotent
Stability Data Does Not Support Expiry: lots do not have stability that supports the use of the container system.