Morphine Sulfate 0.5 mg/ml, vol. 20 ml syringe, Rx only, Hartley Med Ctr Pharmacy, Long Beach, CA
Hartley Medical Center Pharmacy, Incorporated
Lack of Assurance of Sterility
Prescription and over-the-counter medications
Hartley Medical Center Pharmacy, Incorporated
Lack of Assurance of Sterility
Hartley Medical Center Pharmacy, Incorporated
Lack of Assurance of Sterility
Failed Dissolution Specifications: low test results at the 18 month time-point
Presence of Particulate Matter: Glass particles found in the product after reconstitution.
Presence of Particulate Matter: Glass particles found in the product after reconstitution.
Failed Impurities/Degradation Specifications: Observed levels of highest unknown impurity exceeding specification limit at the 3 month stability time point.
Subpotent Drug: failed at the 3 and 6 month stability time points.
Baxter Healthcare
PRESENCE OF PARTICULATE MATTER: Product complaint for the presence of particulate matter identified as an insect.
TexasStar Pharmacy
Lack of assurance of sterility
Labeling: Incorrect or Missing Lot and/or Exp Date: Confirmed customer report of an incorrect expiration date printed on the primary container labeled "01AUG1017" rather than "01AUG2017".
Keystone Laboratories
Microbial Contamination of a Non-Sterile Products: The product had a positive Staphylococcus aureus test result.
Isomeric Pharmacy Solution
Labeling: Incorrect or Missing Lot and/or Exp Date: some vials may be mislabeled with an incorrect "Compounded" date, lot number, and "Do Not Use Beyond" date or BUD (Before Use Date) that may be longer than intended.
Zydus Pharmaceuticals USA
Failed Impurities/Degradation Specifications: Out of specification for a known degradant.
Superpotent Drug: The vitamin supplement contains an extremely high level of vitamin D3 (Cholecalciferol).
Lack of Assurance of Sterility: Some single-use vials may be filled with water rather than the product solution and the firm cannot guarantee the sterility of the water-filled vials.
Abbott's Compounding Pharmacy
Lack of Assurance of Sterility: Firm is recalling all unexpired lots of sterile compounded products after FDA inspection found concerns of lack of sterility assurance.
Abbott's Compounding Pharmacy
Lack of Assurance of Sterility: Firm is recalling all unexpired lots of sterile compounded products after FDA inspection found concerns of lack of sterility assurance.
Abbott's Compounding Pharmacy
Lack of Assurance of Sterility: Firm is recalling all unexpired lots of sterile compounded products after FDA inspection found concerns of lack of sterility assurance.
Abbott's Compounding Pharmacy
Lack of Assurance of Sterility: Firm is recalling all unexpired lots of sterile compounded products after FDA inspection found concerns of lack of sterility assurance.
Dr. Reddy's Laboratories
Failed Tablet/Capsule Specifications: Product recalled due to reports of breakage and leakage of Paricalcitol capsules.