Advanced Pharma recalls
Advanced Pharma appears in 99 official U.S. recall notices indexed by RecallRadar, most recently on 2019-05-08.
Company names are normalized from agency data (legal suffixes removed), so related firms may appear under separate pages.
Recall summary
| Recall notices | 99 |
|---|---|
| Published | 2017-05-31 to 2019-05-08 |
| By agency | FDA Drug (99) |
| By classification | Class II (91), Class I (5), Class III (3) |
| By status | terminated (99) |
| Distribution named in notices | NM, OH, PA, TX, US, WA |
Recalls
- HYDROmorphone 20 mg/100 mL Injectable Solution, Hydromorphone HCl 20 mg 0.9% Sodium Chloride 100 mL, Sterile single use bag, Compounded Dru…
FDA Drug · Class II · 2019-05-08 · Advanced Pharma
Reason: Sub-potency - Glycopyrrolate 0.6 mg/3 mL (0.2 mg per mL) Injectable Solution, 3 mL Sterile single use syringe, For IV or IM use, NDC: 42852-828-22 Avella…
FDA Drug · Class II · 2019-03-27 · Advanced Pharma
Reason: Lack of Assurance of Sterility - 2% Lidocaine HCl Injectable Solution, 100 mg/5 mL (20 mg per mL), 5mL Sterile single use syringe, NDC: 42852-011-67 Avella of Houston 9265…
FDA Drug · Class II · 2019-03-27 · Advanced Pharma
Reason: Lack of Assurance of Sterility - Heparin 5,000 Units/5mL (1,000 Units per mL) Injectable Solution, 5,000 Units in 0.9% Sodium Chloride, QS 5 mL Sterile single use syringe,…
FDA Drug · Class II · 2019-03-27 · Advanced Pharma
Reason: Lack of Assurance of Sterility - Phenylephrine HCl, 400 mcg in 0.9% Sodium Chloride, QS 10 mL Injectable Solution 400 mcg/10 mL (40 mcg per mL), Sterile single use syringe,…
FDA Drug · Class II · 2019-03-27 · Advanced Pharma
Reason: Lack of Assurance of Sterility - Neostigmine Methylsulfate Injection Solution 5 mg/5mL (1 mg per mL), 5mL Sterile single use syringe, For IV use only, NDC: 42852-829-67 Ave…
FDA Drug · Class II · 2019-03-27 · Advanced Pharma
Reason: Lack of Assurance of Sterility - Morphine Sulfate 30 mg/30 mL (1 mg/mL) Injectable Solution Morphine Sulfate 30 mg 0.9% Sodium Chloride QS 30 mL Sterile singe use syringe,…
FDA Drug · Class II · 2019-03-27 · Advanced Pharma
Reason: Lack of Assurance of Sterility - Phenylephrine HCl, 1,200 mcg in 0.9% Sodium Chloride, QS 10 mL Injectable Solution 1,200 mcg/10 mL (120 mcg per mL), Sterile single use syr…
FDA Drug · Class II · 2019-03-27 · Advanced Pharma
Reason: Lack of Assurance of Sterility - Esmolol HCl Injectable Solution 100 mg/10 mL (10 mg per mL)10mL Sterile single use syringe, NDC: 42852-827-61 Avella of Houston 9265 Kirby…
FDA Drug · Class II · 2019-03-27 · Advanced Pharma
Reason: Lack of Assurance of Sterility - Phenylephrine HCl, 1 mg in Sterile Water for Injection, QS 10 mL Injectable Solution 1 mg/10 mL (100 mcg per mL) NDC: 42852-802-61 Avella o…
FDA Drug · Class II · 2019-03-27 · Advanced Pharma
Reason: Lack of Assurance of Sterility - Phenylephrine HCl, 500 mcg in 0.9% Sodium Chloride, QS 5 mL Injectable Solution 500 mcg/5 mL (100 mcg per mL), 5mL Sterile single use syrin…
FDA Drug · Class II · 2019-03-27 · Advanced Pharma
Reason: Lack of Assurance of Sterility - Phenylephrine HCl, 800 mcg in 0.9% Sodium Chloride, QS 10 mL Injectable Solution, 800 mcg/10 mL (80 mcg per mL), 10mL Sterile single use sy…
FDA Drug · Class II · 2019-03-27 · Advanced Pharma
Reason: Lack of Assurance of Sterility - HYDROmorphone HCl 1 mg in 0.9% Sodium Chloride, QS 5 mL Injectable Solution 1 mg/5 mL (0.2 mg per mL), Sterile single use syringe, NDC: 428…
FDA Drug · Class II · 2019-03-27 · Advanced Pharma
Reason: Lack of Assurance of Sterility - fentaNYL 2500 mcg/250 mL Injectable Solution, Fentanyl 0.9% Sodium Chloride, QS, Sterile single use bags, NDC: 42852-210-25 Avella of Houst…
FDA Drug · Class II · 2019-03-27 · Advanced Pharma
Reason: Lack of Assurance of Sterility - fentaNYL 1000 mcg/100 mL Injectable Solution Fentanyl 0.9% Sodium Chloride, QS, 100 mL, Sterile single use bag, NDC: 42852-210-10 Avella of…
FDA Drug · Class II · 2019-03-27 · Advanced Pharma
Reason: Lack of Assurance of Sterility - Phenylephrine HCl, 1 mg in 0.9% Sodium Chloride, QS 10 mL Injectable Solution 1 mg/10 mL (100 mcg per mL), Sterile single use syringe, NDC:…
FDA Drug · Class II · 2019-03-27 · Advanced Pharma
Reason: Lack of Assurance of Sterility - Glycopyrrolate Injectable Solution 1 mg/5 mL (0.2 mg per mL), Sterile single use syringe, NDC: 42852-828-67 Avella of Houston 9265 Kirby Dr…
FDA Drug · Class II · 2019-03-27 · Advanced Pharma
Reason: Lack of Assurance of Sterility - Heparin 10 Units/10 mL 10 Units in 0.45% Sodium Chloride, QS 10 mL, Injectable Solution, Dwell, 10mL Sterile single use syringe, NDC: 42852…
FDA Drug · Class II · 2019-03-27 · Advanced Pharma
Reason: Lack of Assurance of Sterility - Midazolam Benzodiazepine 50 mg/50 mL (1 mg/mL) Injectable Solution, Midazolam HCl 0.9% Sodium Chloride, QS, Sterile single use bag, NDC: 42…
FDA Drug · Class II · 2019-03-27 · Advanced Pharma
Reason: Lack of Assurance of Sterility - 2% Lidocaine HCl Injectable Solution, 60 mg/3 mL (20 mg per mL), 3mL Sterile single use syringe, NDC: 42852-011-22 Avella of Houston 9265 K…
FDA Drug · Class II · 2019-03-27 · Advanced Pharma
Reason: Lack of Assurance of Sterility - Fentanyl in 0.9% Sodium Chloride QS 0.5 mL, 5 mcg/0.5 mL with up to 0.1 mL of overfill Injectable Solution, Sterile single use syringe, Rx…
FDA Drug · Class II · 2019-02-27 · Advanced Pharma
Reason: Labeling: Incorrect expiration date. - Oxytocin 10 Units added to NS 1000 mL (oxytocin and 0.9% Sodium Chloride) Injectable Solution, Approximately 1001 mL Sterile single use bag…
FDA Drug · Class III · 2019-02-27 · Advanced Pharma
Reason: Superpotent Drug: product may contain concentrations of oxytocin higher than what is represented on the label. - Oxytocin 20 Units added to NS 1000 mL (oxytocin and 0.9% Sodium Chloride) Injectable Solution, Approximately 1002 mL Sterile single use bag…
FDA Drug · Class III · 2019-02-27 · Advanced Pharma
Reason: Superpotent Drug: product may contain concentrations of oxytocin higher than what is represented on the label. - Oxytocin 30 Units added to NS 500 mL (oxytocin and 0.9% Sodium Chloride) Injectable Solution, Approximately 503 mL Sterile single use bag,…
FDA Drug · Class III · 2019-02-27 · Advanced Pharma
Reason: Superpotent Drug: product may contain concentrations of oxytocin higher than what is represented on the label. - HEPERAIN 50 mg/50 mL (1mg/mL) Injectable Solution, Heparin Sodium 0.45% Sodium Chloride QS Heparin 50 Units 50 mL, Sterile single use syrin…
FDA Drug · Class II · 2019-01-30 · Advanced Pharma
Reason: 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) - 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…
FDA Drug · Class I · 2019-01-02 · Advanced Pharma
Reason: 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". - 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 5…
FDA Drug · Class II · 2018-07-04 · Advanced Pharma
Reason: Subpotent Drug: final drug concentration is subpotent as compared to the concentration indicated on the label. - 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 Housto…
FDA Drug · Class I · 2018-01-31 · Advanced Pharma
Reason: Subpotent - 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…
FDA Drug · Class II · 2017-12-27 · Advanced Pharma
Reason: Stability Data Does Not Support Expiry: lots do not have stability that supports the use of the container system. - 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 FIV…
FDA Drug · Class I · 2017-12-27 · Advanced Pharma
Reason: Subpotent Drug: found to be below the specification for labeled assay. - 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 FI…
FDA Drug · Class I · 2017-12-27 · Advanced Pharma
Reason: Subpotent Drug: found to be below the specification for labeled assay. - 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 FIV…
FDA Drug · Class II · 2017-12-27 · Advanced Pharma
Reason: Stability Data Does Not Support Expiry: lots do not have stability that supports the use of the container system. - 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 FI…
FDA Drug · Class II · 2017-12-27 · Advanced Pharma
Reason: Stability Data Does Not Support Expiry: lots do not have stability that supports the use of the container system. - 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 pe…
FDA Drug · Class II · 2017-12-27 · Advanced Pharma
Reason: Stability Data Does Not Support Expiry: lots do not have stability that supports the use of the container system. - 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…
FDA Drug · Class I · 2017-12-27 · Advanced Pharma
Reason: Subpotent Drug: found to be below the specification for labeled assay. - 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…
FDA Drug · Class II · 2017-07-19 · Advanced Pharma
Reason: Lack of Assurance of Sterility - 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…
FDA Drug · Class II · 2017-07-19 · Advanced Pharma
Reason: Lack of Assurance of Sterility - 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…
FDA Drug · Class II · 2017-07-19 · Advanced Pharma
Reason: Lack of Assurance of Sterility - 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 via…
FDA Drug · Class II · 2017-07-19 · Advanced Pharma
Reason: Lack of Assurance of Sterility - Dexamethasone Sodium Phosphate all strengths, all dosage forms and all packaging, Rx Only, Avella of Houston, Houston, TX 77054
FDA Drug · Class II · 2017-05-31 · Advanced Pharma
Reason: Labeling: Not Elsewhere Classified: Products may contain synthetic latex and/or natural latex. - Sufentanil Citrate all strengths, all dosage forms and all packaging, Rx Only, Avella of Houston, Houston, TX 77054
FDA Drug · Class II · 2017-05-31 · Advanced Pharma
Reason: Labeling: Not Elsewhere Classified: Products may contain synthetic latex and/or natural latex. - Hydromorphone HCl all strengths, all dosage forms and all packaging, Rx Only, Avella of Houston, Houston, TX 77054
FDA Drug · Class II · 2017-05-31 · Advanced Pharma
Reason: Labeling: Not Elsewhere Classified: Products may contain synthetic latex and/or natural latex. - Vancomycin HCl all strengths, all dosage forms and all packaging, Rx Only, Avella of Houston, Houston, TX 77054
FDA Drug · Class II · 2017-05-31 · Advanced Pharma
Reason: Labeling: Not Elsewhere Classified: Products may contain synthetic latex and/or natural latex. - Norepinephrine Bitartrate all strengths, all dosage forms and all packaging, Rx Only, Avella of Houston, Houston, TX 77054
FDA Drug · Class II · 2017-05-31 · Advanced Pharma
Reason: Labeling: Not Elsewhere Classified: Products may contain synthetic latex and/or natural latex. - Meperidine HCl all strengths, all dosage forms and all packaging, Rx Only, Avella of Houston, Houston, TX 77054
FDA Drug · Class II · 2017-05-31 · Advanced Pharma
Reason: Labeling: Not Elsewhere Classified: Products may contain synthetic latex and/or natural latex. - Dexmedetomidine HCl all strengths, all dosage forms and all packaging, Rx Only, Avella of Houston, Houston, TX 77054
FDA Drug · Class II · 2017-05-31 · Advanced Pharma
Reason: Labeling: Not Elsewhere Classified: Products may contain synthetic latex and/or natural latex. - Ropi/ Epi/ Clon PeriCapsular injection all strengths, all dosage forms and all packaging, Rx Only, Avella of Houston, Houston, TX 77054
FDA Drug · Class II · 2017-05-31 · Advanced Pharma
Reason: Labeling: Not Elsewhere Classified: Products may contain synthetic latex and/or natural latex. - Early TPN (Neonatal) all strengths, all dosage forms and all packaging, Rx Only, Avella of Houston, Houston, TX 77054
FDA Drug · Class II · 2017-05-31 · Advanced Pharma
Reason: Labeling: Not Elsewhere Classified: Products may contain synthetic latex and/or natural latex. - Ketamine HCl all strengths, all dosage forms and all packaging, Rx Only, Avella of Houston, Houston, TX 77054
FDA Drug · Class II · 2017-05-31 · Advanced Pharma
Reason: Labeling: Not Elsewhere Classified: Products may contain synthetic latex and/or natural latex. - Oxytocin all strengths, all dosage forms and all packaging, Rx Only, Avella of Houston, Houston, TX 77054
FDA Drug · Class II · 2017-05-31 · Advanced Pharma
Reason: Labeling: Not Elsewhere Classified: Products may contain synthetic latex and/or natural latex.