Ascorbic Acid, Compounded-Tapioca, 450 mg/mL Injection, 50 mL, Rx Only, Promise Pharmacy Compounding Specialists 31818 US Hwy 19N, Palm Harbor, FL 34684
Promise Pharmacy
💊 Drugs Class I - Dangerous
Lack of sterility assurance.
All Recalls
95,064 total recalls in our database
💊 Drugs Class I - Dangerous
Lack of sterility assurance.
HCG, Human chorionic gonadotropin 5,000 units, injection, Rx Only, Promise Pharmacy Compounding Specialists 31818 US Hwy 19N, Palm Harbor, FL 34684
Promise Pharmacy
💊 Drugs Class I - Dangerous
Lack of sterility assurance.
Procaine HCl, 2% injection, 10ml vial, Rx Only, Promise Pharmacy Compounding Specialists 31818 US Hwy 19N, Palm Harbor, FL 34684
Promise Pharmacy
💊 Drugs Class I - Dangerous
Lack of sterility assurance.
Methylcobalamin lyophilized, 10,000 mcg Injection, Rx Only, Promise Pharmacy Compounding Specialists 31818 US Hwy 19N, Palm Harbor, FL 34684
Promise Pharmacy
💊 Drugs Class I - Dangerous
Lack of sterility assurance.
MAGnesium 2gm sulfate, added to D5W 50 mL, Volume: 54 mL, Sterile single use bag, Compounded by Avella Specialty Pharmacy 24416 N 19th Avenue, Phoenix, AZ 85085 (877) 794-0404, NDC 42852-902-05.
Avella of Deer Valley, Inc. Store 38
💊 Drugs Class I - Dangerous
Labeling: Incorrect or Missing Lot and/or Exp Date:The product labels contain a Two-Dimensional ( 2D ) barcode that, when scanned, reveals information specific to the batch of the labeled product, including Expiration Date. The expiration date included within these 2D barcodes is incorrect and does not match the correct expiration date listed on the face of the label itself.
💊 Drugs Class I - Dangerous
Lack of sterility assurance.
💊 Drugs Class I - Dangerous
Failed Impurities/Degradation Specifications: Out of specification test results in related substance at three-month long term stability study was obtained.
Sermorelin 9 mg injection, Rx Only, Promise Pharmacy Compounding Specialists 31818 US Hwy 19N, Palm Harbor, FL 34684
Promise Pharmacy
💊 Drugs Class I - Dangerous
Lack of sterility assurance.
💊 Drugs Class I - Dangerous
Labeling: Label Error on Declared Strength; the pre-printed text on the primary infusion bag and the NDC incorrectly identifies the product as Levetiracetam in 0.75% Sodium Chloride (1000 mg/100 mL) however, the external foil pouch correctly identifies the product as Levetiracetam in 0.54% Sodium Chloride Injection (1,500/100 mL).
Glutathione Injection, 200 mg/mL, 10 mL, Rx Only, Promise Pharmacy Compounding Specialists 31818 US Hwy 19N, Palm Harbor, FL 34684
Promise Pharmacy
💊 Drugs Class I - Dangerous
Lack of sterility assurance.
Vitamin D3 50,000iu/mL, injection 5 mL, Rx Only, Promise Pharmacy Compounding Specialists 31818 US Hwy 19N, Palm Harbor, FL 34684
Promise Pharmacy
💊 Drugs Class I - Dangerous
Lack of sterility assurance.
💊 Drugs Class I - Dangerous
CGMP Deviations: Active Pharmaceutical Ingredient (API) manufacturer is on FDA Import Alert.
Medtronic implantable pulse generator: RELIA, Dual chamber pacemaker (VDD): (a) Model Number RED01 (b) Model Number REDR01 (c) Model Number REVDD01
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
🏥 Medical Devices Class I - Dangerous
A subset of Medtronic dual chamber pacemakers distributed worldwide between 10 March 2017 and 7 January 2019 under the brand names Adapta, Versa, and Sensia when programmed to a dual chamber mode with atrial-sensing, may experience a circuit error that affects device functionality
Genius Knee Cemented Tibial Component Product Usage: Knee replacement component
Signature Orthopedics Pty Limited
🏥 Medical Devices Class I - Dangerous
Product mix up
OMNI K1 Broach Handle, Product Code HS-10054
OMNIlife science
🏥 Medical Devices Class I - Dangerous
There is a potential for the inner pin of the handle to become loose and fall out.
21Y15 MagValve Product Usage: The PushValves/ MagValves is intended exclusively for the prosthetic fitting of lower limb amputees. The valve is a threadless one-way valve. It is used to evacuate air from the prosthetic socket.
Ottobock Orthopedic Industrie
🏥 Medical Devices Class I - Dangerous
Some of the installed valve-inserts have a diameter smaller than the specification.
🏥 Medical Devices Class I - Dangerous
Evidence supports that when customers performed a fuse replacement as part of a March 2017 field action, the fuse clips became stretched and were no longer mechanically tight with the fuse, creating a host spot that led to discoloration on the board due to overheating and shut down of the device.
🏥 Medical Devices Class I - Dangerous
There is a potential that Wedge IDs were not included in the DICOM RT PLAN sent from the TPS, which will cause the field in MOSAIQ to be created with no wedge. Treatment of a field without the planned wedge will receive more dose than the treatment plan indicates.
🏥 Medical Devices Class I - Dangerous
A software update is being issued to correct multiple issues identified in the previous software version.