Advanced Pharma

Labeling; Label Error on Declared Strength; label incorrectly states the concentration as 50 mg/50 mL (1 mg/mL) rather than the fully accurate concentration as 50 Units/50 mL (1 Unit/mL)

Jan 15, 2019 Compounded Drugs View Details →

Phenylephrine HCl, 1 mg in Sterile Water for Injection, QS 10mL Injectable Solution, 1 mg/10 mL incorrectly labeled as (10 mcg per mL), 10 mL syringe, Rx only, Avella of Houston, 9265 Kirby Dr., Houston, TX 77054, (877) 794-0404; NDC: 42852-802-61.

Class I - Dangerous

Labeling: Label Error on Declared Strength: Label incorrectly lists concentration as "10 mcg per mL" rather than the correct concentration of "100 mcg per mL".

Nov 29, 2018 Prescription Drugs View Details →

fentanyl Citrate USP 5 mcg in 0.9% Sodium Chloride USP 0.5 mL, 10 mcg per mL prefilled syringe, Rx only, Advanced Pharma an FDA Regulated 503B Outsourcing Facility 9265 Kirby Dr., Houston, TX 77054, NDC 15082-210-72.

Class I - Dangerous

Subpotent Drug: final drug concentration is subpotent as compared to the concentration indicated on the label.

Jun 20, 2018 Prescription Drugs View Details →

MAGnesium 2 gm in NS 100 mL Magnesium SULfate (USP) 0.9% Sodium Chloride (USP) in 100 mL Sterile single dose bag, Rx only, Avella of Houston 9265 Katy Dr., Houston, TX ---NDC 42852-907-10

Class I - Dangerous

Subpotent

Jan 5, 2018 Prescription Drugs View Details →

NitroGlycerin (2 mg/10 mL in 5% Dextrose Inj, USP QS 10mL (200 mcg per mL), 10 mL Sterile single dose syringe, packaged in 5 x 5 (TWENTY FIVE) syringes per box, Rx only, Advanced Pharma, 9265 Kirby Dr., Houston, TX 77054, NDC 15082-863-61.

Class I - Dangerous

Stability Data Does Not Support Expiry: lots do not have stability that supports the use of the container system.

Jun 9, 2017 Prescription Drugs Nationwide View Details →

NitroGlycerin (1 mg/5 mL) 1 mg in 5% Dextrose Inj, USP QS 5 mL (200 mcg per mL), 5 mL Sterile single dose syringe, packaged in 8 x 5 (FORTY) syringes per box, Rx only, Advanced Pharma, 9265 Kirby Dr., Houston, TX 77054, NDC 15082-863-67.

Class I - Dangerous

Subpotent Drug: found to be below the specification for labeled assay.

Jun 9, 2017 Prescription Drugs Nationwide View Details →

NitroGlycerin 100 mcg/mL QS 5% Dextrose Inj, USP (2 mg per 20 mL) 20 mL Sterile single dose syringe, packaged in 10 x 5 (FIFTY) syringes per box, Rx only, Advanced Pharma, 9265 Kirby Dr., Houston, TX 77054, NDC 15082-818-62.

Class I - Dangerous

Stability Data Does Not Support Expiry: lots do not have stability that supports the use of the container system.

Jun 9, 2017 Prescription Drugs Nationwide View Details →

NitroGlycerin 1 mg/10 mL in 5% Dextrose Inj, USP QS 10mL (100 mcg per mL), 10 mL Sterile single dose syringe, packaged in 5 x 5 (TWENTY FIVE) syringes per box, Rx only, Advanced Pharma, 9265 Kirby Dr., Houston, TX 77054, NDC 15082-818-61.

Class I - Dangerous

Stability Data Does Not Support Expiry: lots do not have stability that supports the use of the container system.

Jun 9, 2017 Prescription Drugs Nationwide View Details →

NitroGlycerin (2 mg/10 mL in 5% Dextrose Inj, USP QS 10mL (200 mcg per mL), 10 mL Sterile single dose syringe, packaged in 5 x 5 (TWENTY FIVE) syringes per box, Rx only, Advanced Pharma, 9265 Kirby Dr., Houston, TX 77054, NDC 15082-863-61.

Class I - Dangerous

Subpotent Drug: found to be below the specification for labeled assay.

Jun 9, 2017 Prescription Drugs Nationwide View Details →

NitroGlycerin (1 mg/5 mL) 1 mg in 5% Dextrose Inj, USP QS 5 mL (200 mcg per mL), 5 mL Sterile single dose syringe, packaged in 8 x 5 (FORTY) syringes per box, Rx only, Advanced Pharma, 9265 Kirby Dr., Houston, TX 77054, NDC 15082-863-67.

Class I - Dangerous

Stability Data Does Not Support Expiry: lots do not have stability that supports the use of the container system.

Jun 9, 2017 Prescription Drugs Nationwide View Details →

NitroGlycerin 1 mg/10 mL in 5% Dextrose Inj, USP QS 10mL (100 mcg per mL), 10 mL Sterile single dose syringe, packaged in 5 x 5 (TWENTY FIVE) syringes per box, Rx only, Advanced Pharma, 9265 Kirby Dr., Houston, TX 77054, NDC 15082-818-61.

Class I - Dangerous

Subpotent Drug: found to be below the specification for labeled assay.

Jun 9, 2017 Prescription Drugs Nationwide View Details →

QUELICIN (Succinylcholine Chloride) Injection, USP 20 mg/mL in a) 5 mL vial (NDC 15082-814-67), b) 7mL vial (NDC 15082-814-79), c) 10mL vial (NDC 15082-814-61), Repackaged by Advanced Pharm, 9265 Kirby Dr., Houston, TX 77054 (877) 794-0404.

Class I - Dangerous

Lack of Assurance of Sterility

Jun 22, 2017 Prescription Drugs Nationwide View Details →

Potassium Phosphate (USP) QS 0.9% Sodium Chloride (USP) 250 mL 20 mmol in NS 250mL Bag, Advanced Pharma, 9265 Kirby Dr., Houston, TX 77054 (877) 794-0404. NDC15082-926-25

Class I - Dangerous

Lack of Assurance of Sterility

Jun 22, 2017 Other Drugs Nationwide View Details →

Potassium Phosphate (USP) QS 0.9% Sodium Chloride (USP) 250 mL 15 mmol in NS 250mL Bag, Advanced Pharma, 9265 Kirby Dr., Houston, TX 77054 (877) 794-0404. NDC15082-922-25

Class I - Dangerous

Lack of Assurance of Sterility

Jun 22, 2017 Other Drugs Nationwide View Details →

Potassium Phosphate (USP) QS 0.9% Sodium Chloride (USP) 250 mL 30 mmol in NS 250mL Bag, Advanced Pharma, 9265 Kirby Dr., Houston, TX 77054 (877) 794-0404. NDC15082-924-25

Class I - Dangerous

Lack of Assurance of Sterility

Jun 22, 2017 Other Drugs Nationwide View Details →