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Showing 13561–13580 of 14370 results

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Glimepiride Tablets (Qualitest) – Oversized Tablet (2013)

Failed Tablet/Capsule Specifications: One oversized tablet was found in a sealed 100 count bottle of Glimepiride at the retail level.

Class IIModerate

FDAApr 19, 2013Nationwide• Qualitest Pharmaceuticals

Lidocaine Bupivacaine Injection (Abrams Royal) – Non-Sterile (2013)

Non-Sterility

FDAApr 19, 2013TX• Abrams Royal Pharmacy

Amoxicillin Capsules (Sandoz) – Foreign Substance (2013)

Presence of Foreign Substance, Sandoz is recalling certain lots of Amoxicillin Capsules, USP 500 mg due to potential contamination with fragments of stainless steel wire mesh.

Class IIModerate

FDAApr 18, 2013Nationwide• Sandoz Incorporated

Sodium Tetradecyl Sulfate Injectable (Axium Healthcare) – sterility concern (2013)

Lack of Assurance of Sterility:All sterile products compounded, repackaged, and distributed by this compounding pharmacy due to lack of sterility assurance and concerns associated with the quality control processes.

Class IIModerate

FDAApr 17, 2013CO, GA, MI +1 more• Axium Healthcare Pharmacy dba Balanced Solutions Compounding

NORepinephrine IV Sodium Chloride (Unique Pharmaceutical) – mold contamination (2013)

Lack of Assurance of Sterility: A mold like substance was discovered on the surface of an unopened bag of Sodium Chloride 0.9% while prepping the bag for production.

Class IIModerate

FDAApr 17, 2013PA, TN, TX• Unique Pharmaceutical, Ltd

Betamethasone Injectable (Axium Healthcare) – sterility concern (2013)

Lack of Assurance of Sterility:All sterile products compounded, repackaged, and distributed by this compounding pharmacy due to lack of sterility assurance and concerns associated with the quality control processes.

Class IIModerate

FDAApr 17, 2013CO, GA, MI +1 more• Axium Healthcare Pharmacy dba Balanced Solutions Compounding

Triamcinolone Acetonide Injectable (Axium Healthcare) – sterility concern (2013)

Lack of Assurance of Sterility:All sterile products compounded, repackaged, and distributed by this compounding pharmacy due to lack of sterility assurance and concerns associated with the quality control processes.

Class IIModerate

FDAApr 17, 2013CO, GA, MI +1 more• Axium Healthcare Pharmacy dba Balanced Solutions Compounding

Bacteriostatic Water Injectable (Axium Healthcare) – sterility concern (2013)

Lack of Assurance of Sterility:All sterile products compounded, repackaged, and distributed by this compounding pharmacy due to lack of sterility assurance and concerns associated with the quality control processes.

Class IIModerate

FDAApr 17, 2013CO, GA, MI +1 more• Axium Healthcare Pharmacy dba Balanced Solutions Compounding

Triamcinolone Diacetate Injectable (Axium Healthcare) – sterility concern (2013)

Lack of Assurance of Sterility:All sterile products compounded, repackaged, and distributed by this compounding pharmacy due to lack of sterility assurance and concerns associated with the quality control processes.

Class IIModerate

FDAApr 17, 2013CO, GA, MI +1 more• Axium Healthcare Pharmacy dba Balanced Solutions Compounding

Methylcobalamin Folic Acid Injectable (Axium Healthcare) – sterility concern (2013)

Lack of Assurance of Sterility:All sterile products compounded, repackaged, and distributed by this compounding pharmacy due to lack of sterility assurance and concerns associated with the quality control processes.

Class IIModerate

FDAApr 17, 2013CO, GA, MI +1 more• Axium Healthcare Pharmacy dba Balanced Solutions Compounding

Phosphatidylcholine Injectable (Axium Healthcare) – sterility concern (2013)

Lack of Assurance of Sterility:All sterile products compounded, repackaged, and distributed by this compounding pharmacy due to lack of sterility assurance and concerns associated with the quality control processes.

Class IIModerate

FDAApr 17, 2013CO, GA, MI +1 more• Axium Healthcare Pharmacy dba Balanced Solutions Compounding

DMSO 50% Bladder Irrigation (Axium Healthcare) – sterility concern (2013)

Lack of Assurance of Sterility:All sterile products compounded, repackaged, and distributed by this compounding pharmacy due to lack of sterility assurance and concerns associated with the quality control processes.

Class IIModerate

FDAApr 17, 2013CO, GA, MI +1 more• Axium Healthcare Pharmacy dba Balanced Solutions Compounding

BiMix Plus Injectable (Axium Healthcare) – sterility concern (2013)

Lack of Assurance of Sterility:All sterile products compounded, repackaged, and distributed by this compounding pharmacy due to lack of sterility assurance and concerns associated with the quality control processes.

Class IIModerate

FDAApr 17, 2013CO, GA, MI +1 more• Axium Healthcare Pharmacy dba Balanced Solutions Compounding

Triamcinolone Hexacetonide Injectable (Axium Healthcare) – sterility concern (2013)

Lack of Assurance of Sterility:All sterile products compounded, repackaged, and distributed by this compounding pharmacy due to lack of sterility assurance and concerns associated with the quality control processes.

Class IIModerate

FDAApr 17, 2013CO, GA, MI +1 more• Axium Healthcare Pharmacy dba Balanced Solutions Compounding

Methylprednisolone Acetate Injectable (Axium Healthcare) – sterility concern (2013)

Lack of Assurance of Sterility:All sterile products compounded, repackaged, and distributed by this compounding pharmacy due to lack of sterility assurance and concerns associated with the quality control processes.

Class IIModerate

FDAApr 17, 2013CO, GA, MI +1 more• Axium Healthcare Pharmacy dba Balanced Solutions Compounding

QuadMix Injectable (Axium Healthcare) – sterility concern (2013)

Lack of Assurance of Sterility:All sterile products compounded, repackaged, and distributed by this compounding pharmacy due to lack of sterility assurance and concerns associated with the quality control processes.

Class IIModerate

FDAApr 17, 2013CO, GA, MI +1 more• Axium Healthcare Pharmacy dba Balanced Solutions Compounding

TriMix PGE Stock Injectable (Axium Healthcare) – sterility concern (2013)

Lack of Assurance of Sterility:All sterile products compounded, repackaged, and distributed by this compounding pharmacy due to lack of sterility assurance and concerns associated with the quality control processes.

Class IIModerate

FDAApr 17, 2013CO, GA, MI +1 more• Axium Healthcare Pharmacy dba Balanced Solutions Compounding

Quadmix Custom Injectable (Axium Healthcare) – sterility concern (2013)

Lack of Assurance of Sterility:All sterile products compounded, repackaged, and distributed by this compounding pharmacy due to lack of sterility assurance and concerns associated with the quality control processes.

Class IIModerate

FDAApr 17, 2013CO, GA, MI +1 more• Axium Healthcare Pharmacy dba Balanced Solutions Compounding

Trimix Injectable (Axium Healthcare) – sterility concern (2013)

Lack of Assurance of Sterility:All sterile products compounded, repackaged, and distributed by this compounding pharmacy due to lack of sterility assurance and concerns associated with the quality control processes.

Class IIModerate

FDAApr 17, 2013CO, GA, MI +1 more• Axium Healthcare Pharmacy dba Balanced Solutions Compounding

Cyclosporin in Corn Oil Injectable (Axium Healthcare) – sterility concern (2013)

Lack of Assurance of Sterility:All sterile products compounded, repackaged, and distributed by this compounding pharmacy due to lack of sterility assurance and concerns associated with the quality control processes.

Class IIModerate

FDAApr 17, 2013CO, GA, MI +1 more• Axium Healthcare Pharmacy dba Balanced Solutions Compounding

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