Food, drugs, devices › Advanced Pharma Inc.

Drug recall: Oxytocin 10 Units added to NS 1000 mL (oxytocin and 0.9% Sodium Chloride) Injectable Solution, Approximately 1001 mL Ste

FDA enforcement event 82089 · Class III · initiated 6 Feb 2019 · status Terminated · terminated 30 Oct 2019

DrugVoluntary: Firm initiated3 product recordsHouston, TX

Advanced Pharma Inc. (Houston, TX) initiated this drug recall on 6 Feb 2019; FDA lists 3 product records under event 82089, classified Class III.

FDA defines Class III as a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences. 22% of the 362 drug enforcement events initiated in 2019 carry the same class.

Status: Terminated, terminated 30 Oct 2019. Initiation: voluntary: firm initiated. Advanced Pharma Inc. has 11 enforcement events on this register, with a median of 1 product record per event.

Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.

Recalling firm

Advanced Pharma Inc., Houston, TX.

Reason for recall

"Superpotent Drug: product may contain concentrations of oxytocin higher than what is represented on the label."

Distribution

"Nationwide in the USA."

Product records

Recall number	Product	Quantity	Class	Status	Report date
D-0497-2019	Oxytocin 10 Units added to NS 1000 mL (oxytocin and 0.9% Sodium Chloride) Injectable Solution, Approximately 1001 mL Sterile single use bag, Rx only, Avella of Houston, 9265 Kirby Dr., Houston, TX 77054, NDC 42852-730-99.	12 bags	Class III	Terminated	27 Feb 2019
D-0498-2019	Oxytocin 20 Units added to NS 1000 mL (oxytocin and 0.9% Sodium Chloride) Injectable Solution, Approximately 1002 mL Sterile single use bag, Rx only, Avella of Houston, 9265 Kirby Dr., Houston, TX 77054, NDC 42852-703-99.	672 bags	Class III	Terminated	27 Feb 2019
D-0499-2019	Oxytocin 30 Units added to NS 500 mL (oxytocin and 0.9% Sodium Chloride) Injectable Solution, Approximately 503 mL Sterile single use bag, Rx only, Avella of Houston, 9265 Kirby Dr., Houston, TX 77054, NDC 42852-706-50.	1460 bottles	Class III	Terminated	27 Feb 2019

Context

22%of 2019 drug events are Class III362 events that year

3product records in this eventfirm median: 1

11events on this register for the firm

Other enforcement events for Advanced Pharma Inc.

Initiated	Product (first record)	Type	Class	Records
26 Apr 2019	HYDROmorphone 20 mg/100 mL Injectable Solution, Hydromorphone HCl 20 mg 0.9% Sodium Chloride 100 mL, Sterile single use	Drug	Class II	1
13 Mar 2019	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 us	Drug	Class II	19
6 Feb 2019	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 sing	Drug	Class II	1
15 Jan 2019	HEPERAIN 50 mg/50 mL (1mg/mL) Injectable Solution, Heparin Sodium 0.45% Sodium Chloride QS Heparin 50 Units 50 mL, Steri	Drug	Class II	1
29 Nov 2018	Phenylephrine HCl, 1 mg in Sterile Water for Injection, QS 10mL Injectable Solution, 1 mg/10 mL incorrectly labeled as (	Drug	Class I	1
20 Jun 2018	fentanyl Citrate USP 5 mcg in 0.9% Sodium Chloride USP 0.5 mL, 10 mcg per mL prefilled syringe, Rx only, Advanced Pharma	Drug	Class II	1
5 Jan 2018	MAGnesium 2 gm in NS 100 mL Magnesium SULfate (USP) 0.9% Sodium Chloride (USP) in 100 mL Sterile single dose bag, Rx onl	Drug	Class I	1
22 Jun 2017	QUELICIN (Succinylcholine Chloride) Injection, USP 20 mg/mL in a) 5 mL vial (NDC 15082-814-67), b) 7mL vial (NDC 15082-8	Drug	Class II	4
9 Jun 2017	NitroGlycerin 1 mg/10 mL in 5% Dextrose Inj, USP QS 10mL (100 mcg per mL), 10 mL Sterile single dose syringe, packaged i	Drug	Class I	7
22 Feb 2017	Bupivacaine HCl in 0.9% Sodium Chloride all strengths, all dosage forms and all packaging, Rx Only, Avella of Houston, H	Drug	Class II	60

All 11 events for Advanced Pharma Inc.

Questions and answers

Why was this drug recalled?

FDA's record gives the reason for recall as: "Superpotent Drug: product may contain concentrations of oxytocin higher than what is represented on the label."

What does Class III mean?

FDA classifies recalls by relative degree of health hazard. Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.

Where was the product distributed?

FDA's distribution pattern field reads: "Nationwide in the USA."

Is the recall still ongoing?

FDA lists the status as Terminated; the termination date is 30 Oct 2019. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.

Where does this data come from?

openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.

Provenance

Source: openFDA drug enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.