Drug recall: Bupivacaine HCl in 0.9% Sodium Chloride all strengths, all dosage forms and all packaging, Rx Only, Avella of Houston…

Class II FDA enforcement event 76561. Recall start date: 22 Feb 2017. Status in the FDA record: Terminated. Termination date: 18 Oct 2017.

Reason for recall, in the words of FDA

Labeling: Not Elsewhere Classified: Products may contain synthetic latex and/or natural latex.

Class II, in the words of FDA

a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote

Advanced Pharma Inc. started this drug recall on 22 Feb 2017. The firm address in the FDA record is in Houston, TX. FDA put the recall in Class II. FDA event 76561 has 60 product records. The first FDA enforcement report date is 31 May 2017. The record gives the status Terminated, with the termination date 18 Oct 2017.

FDA enforcement report The 60 product records

It is important to note that most of the time recall classifications are determined after the recalling firm provides all of the information needed to determine the risk posed to public health. The classification and posting in the FDA Enforcement Report should not be seen as an expansion or change to a firm’s voluntary public warning.
FDA publishes these words. Source: FDA, Enforcement Reports, Important Note, read on 1 Oct 2026. openFDA export of 28 Sep 2026.

Distribution

In the words of FDA.

U.S. Nationwide

Recalling firm

Advanced Pharma Inc., Houston, TX.

Recalling firm: The firm that the FDA record names for a recall.

FDA records how the recall started: Voluntary: Firm initiated.

Products

60 product records in the event.

FDA event 76561: product records
Recall number	Product	Class	Status	Report date
D-0794-2017	Bupivacaine HCl in 0.9% Sodium Chloride all strengths, all dosage forms and all packaging, Rx Only, Avella of Houston, Houston, TX 77054	Class II	Terminated	31 May 2017
D-0795-2017	Ropivacaine HCl in 0.9% Sodium Chloride all strengths, all dosage forms and all packaging, Rx Only, Avella of Houston, Houston, TX 77054	Class II	Terminated	31 May 2017
D-0796-2017	Lidocaine all strengths, all dosage forms and all packaging, Rx Only, Avella of Houston, Houston, TX 77054	Class II	Terminated	31 May 2017
D-0797-2017	Nalbuphine all strengths, all dosage forms and all packaging, Rx Only, Avella of Houston, Houston, TX 77054	Class II	Terminated	31 May 2017
D-0798-2017	RECK PeriCapsular injection all strengths, all dosage forms and all packaging, Rx Only, Avella of Houston, Houston, TX 77054	Class II	Terminated	31 May 2017
D-0799-2017	NOVA PeriCapsular injection all strengths, all dosage forms and all packaging, Rx Only, Avella of Houston, Houston, TX 77054	Class II	Terminated	31 May 2017
D-0800-2017	Ofirmev (Acetaminophen) injection all strengths, all dosage forms and all packaging, Rx Only, Avella of Houston, Houston, TX 77054	Class II	Terminated	31 May 2017
D-0801-2017	Ropi/ Epi/ Clon PeriCapsular injection all strengths, all dosage forms and all packaging, Rx Only, Avella of Houston, Houston, TX 77054	Class II	Terminated	31 May 2017
D-0802-2017	NICU STARTER TPN all strengths, all dosage forms and all packaging, Rx Only, Avella of Houston, Houston, TX 77054	Class II	Terminated	31 May 2017
D-0803-2017	TPN Neonatal all strengths, all dosage forms and all packaging, Rx Only, Avella of Houston, Houston, TX 77054	Class II	Terminated	31 May 2017
D-0804-2017	Standard Starter TPN all strengths, all dosage forms and all packaging, Rx Only, Avella of Houston, Houston, TX 77054	Class II	Terminated	31 May 2017
D-0805-2017	Early TPN (Neonatal) all strengths, all dosage forms and all packaging, Rx Only, Avella of Houston, Houston, TX 77054	Class II	Terminated	31 May 2017
D-0806-2017	Early Baby TPN (Neonatal) all strengths, all dosage forms and all packaging, Rx Only, Avella of Houston, Houston, TX 77054	Class II	Terminated	31 May 2017
D-0807-2017	ADD HEPARIN PF 50 Units ONLY TO TPN all strengths, all dosage forms and all packaging, Rx Only, Avella of Houston, Houston, TX 77054	Class II	Terminated	31 May 2017
D-0808-2017	Sufentanil Citrate all strengths, all dosage forms and all packaging, Rx Only, Avella of Houston, Houston, TX 77054	Class II	Terminated	31 May 2017
D-0809-2017	Fentanyl Citrate all strengths, all dosage forms and all packaging, Rx Only, Avella of Houston, Houston, TX 77054	Class II	Terminated	31 May 2017
D-0810-2017	Hydromorphone HCl all strengths, all dosage forms and all packaging, Rx Only, Avella of Houston, Houston, TX 77054	Class II	Terminated	31 May 2017
D-0811-2017	Meperidine HCl all strengths, all dosage forms and all packaging, Rx Only, Avella of Houston, Houston, TX 77054	Class II	Terminated	31 May 2017
D-0812-2017	Morphine Sulfate all strengths, all dosage forms and all packaging, Rx Only, Avella of Houston, Houston, TX 77054	Class II	Terminated	31 May 2017
D-0813-2017	Ketamine HCl all strengths, all dosage forms and all packaging, Rx Only, Avella of Houston, Houston, TX 77054	Class II	Terminated	31 May 2017
D-0814-2017	Midazolam HCl all strengths, all dosage forms and all packaging, Rx Only, Avella of Houston, Houston, TX 77054	Class II	Terminated	31 May 2017
D-0815-2017	Lorazepam HCl all strengths, all dosage forms and all packaging, Rx Only, Avella of Houston, Houston, TX 77054	Class II	Terminated	31 May 2017
D-0816-2017	Methohexital Sodium all strengths, all dosage forms and all packaging, Rx Only, Avella of Houston, Houston, TX 77054	Class II	Terminated	31 May 2017
D-0817-2017	Cefazolin all strengths, all dosage forms and all packaging, Rx Only, Avella of Houston, Houston, TX 77054	Class II	Terminated	31 May 2017
D-0818-2017	Vancomycin HCl all strengths, all dosage forms and all packaging, Rx Only, Avella of Houston, Houston, TX 77054	Class II	Terminated	31 May 2017
D-0819-2017	Penicillin G Potassium all strengths, all dosage forms and all packaging, Rx Only, Avella of Houston, Houston, TX 77054	Class II	Terminated	31 May 2017
D-0820-2017	Gentamicin Sulfate all strengths, all dosage forms and all packaging, Rx Only, Avella of Houston, Houston, TX 77054	Class II	Terminated	31 May 2017
D-0821-2017	Oxytocin all strengths, all dosage forms and all packaging, Rx Only, Avella of Houston, Houston, TX 77054	Class II	Terminated	31 May 2017
D-0822-2017	Heparin sodium all strengths, all dosage forms and all packaging, Rx Only, Avella of Houston, Houston, TX 77054	Class II	Terminated	31 May 2017
D-0823-2017	0.9% Sodium Chloride Slip Tip all strengths, all dosage forms and all packaging, Rx Only, Avella of Houston, Houston, TX 77054	Class II	Terminated	31 May 2017
D-0824-2017	Diltiazem HCl all strengths, all dosage forms and all packaging, Rx Only, Avella of Houston, Houston, TX 77054	Class II	Terminated	31 May 2017
D-0825-2017	Phenylephrine HCl all strengths, all dosage forms and all packaging, Rx Only, Avella of Houston, Houston, TX 77054	Class II	Terminated	31 May 2017
D-0826-2017	Ephedrine Sulfate all strengths, all dosage forms and all packaging, Rx Only, Avella of Houston, Houston, TX 77054	Class II	Terminated	31 May 2017
D-0827-2017	Norepinephrine Bitartrate all strengths, all dosage forms and all packaging, Rx Only, Avella of Houston, Houston, TX 77054	Class II	Terminated	31 May 2017
D-0828-2017	Epinephrine HCl all strengths, all dosage forms and all packaging, Rx Only, Avella of Houston, Houston, TX 77054	Class II	Terminated	31 May 2017
D-0829-2017	Calcium Gluconate all strengths, all dosage forms and all packaging, Rx Only, Avella of Houston, Houston, TX 77054	Class II	Terminated	31 May 2017
D-0830-2017	Amiodarone all strengths, all dosage forms and all packaging, Rx Only, Avella of Houston, Houston, TX 77054	Class II	Terminated	31 May 2017
D-0831-2017	Succinylcholine Chloride all strengths, all dosage forms and all packaging, Rx Only, Avella of Houston, Houston, TX 77054	Class II	Terminated	31 May 2017
D-0832-2017	Adenosine all strengths, all dosage forms and all packaging, Rx Only, Avella of Houston, Houston, TX 77054	Class II	Terminated	31 May 2017
D-0833-2017	Nitroglycerin all strengths, all dosage forms and all packaging, Rx Only, Avella of Houston, Houston, TX 77054	Class II	Terminated	31 May 2017
D-0834-2017	Nicardipine HCl all strengths, all dosage forms and all packaging, Rx Only, Avella of Houston, Houston, TX 77054	Class II	Terminated	31 May 2017
D-0835-2017	Rocuronium Bromide all strengths, all dosage forms and all packaging, Rx Only, Avella of Houston, Houston, TX 77054	Class II	Terminated	31 May 2017
D-0836-2017	Labetalol HCl all strengths, all dosage forms and all packaging, Rx Only, Avella of Houston, Houston, TX 77054	Class II	Terminated	31 May 2017
D-0837-2017	Esmolol HCl all strengths, all dosage forms and all packaging, Rx Only, Avella of Houston, Houston, TX 77054	Class II	Terminated	31 May 2017
D-0838-2017	Glycopyrrolate all strengths, all dosage forms and all packaging, Rx Only, Avella of Houston, Houston, TX 77054	Class II	Terminated	31 May 2017
D-0839-2017	Neostigmine Methylsulfate all strengths, all dosage forms and all packaging, Rx Only, Avella of Houston, Houston, TX 77054	Class II	Terminated	31 May 2017
D-0840-2017	Atropine Sulfate all strengths, all dosage forms and all packaging, Rx Only, Avella of Houston, Houston, TX 77054	Class II	Terminated	31 May 2017
D-0841-2017	Betamethasone Sodium Phosphate & Betamethasone Acetate all strengths, all dosage forms and all packaging, Rx Only, Avella of Houston, Houston, TX 77054	Class II	Terminated	31 May 2017
D-0842-2017	Famotidine HCl all strengths, all dosage forms and all packaging, Rx Only, Avella of Houston, Houston, TX 77054	Class II	Terminated	31 May 2017
D-0843-2017	Ondansetron HCl all strengths, all dosage forms and all packaging, Rx Only, Avella of Houston, Houston, TX 77054	Class II	Terminated	31 May 2017
D-0844-2017	Bumetadine all strengths, all dosage forms and all packaging, Rx Only, Avella of Houston, Houston, TX 77054	Class II	Terminated	31 May 2017
D-0845-2017	Dexamethasone Sodium Phosphate all strengths, all dosage forms and all packaging, Rx Only, Avella of Houston, Houston, TX 77054	Class II	Terminated	31 May 2017
D-0846-2017	Dexmedetomidine HCl all strengths, all dosage forms and all packaging, Rx Only, Avella of Houston, Houston, TX 77054	Class II	Terminated	31 May 2017
D-0847-2017	Cardioplegic Solution Maintenance all strengths, all dosage forms and all packaging, Rx Only, Avella of Houston, Houston, TX 77054	Class II	Terminated	31 May 2017
D-0848-2017	Magnesium Sulfate all strengths, all dosage forms and all packaging, Rx Only, Avella of Houston, Houston, TX 77054	Class II	Terminated	31 May 2017
D-0849-2017	Potassium Phosphate all strengths, all dosage forms and all packaging, Rx Only, Avella of Houston, Houston, TX 77054	Class II	Terminated	31 May 2017
D-0850-2017	Sodium Phosphate all strengths, all dosage forms and all packaging, Rx Only, Avella of Houston, Houston, TX 77054	Class II	Terminated	31 May 2017
D-0851-2017	Sodium Citrate all strengths, all dosage forms and all packaging, Rx Only, Avella of Houston, Houston, TX 77054	Class II	Terminated	31 May 2017
D-0852-2017	Fentanyl Citrate with Ropivacaine HCl all strengths, all dosage forms and all packaging, Rx Only, Avella of Houston, Houston, TX 77054	Class II	Terminated	31 May 2017
D-0853-2017	Fentanyl Citrate and Bupivacaine HCl all strengths, all dosage forms and all packaging, Rx Only, Avella of Houston, Houston, TX 77054	Class II	Terminated	31 May 2017

openFDA, about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports. Source: openFDA, Drug Recall Enforcement Reports, Disclaimer.

Enforcement report: The FDA publication that lists recalls. It has one record for each product of a recall.

Enforcement event: All the product records that have one FDA event number. This site shows one event on one page.

Class II: The middle of the three FDA recall classes.

The event in context

Drug events that started in 2017: 343
Share of these events in Class II: 57%
Product records in this event: 60Median of the firm: 1
Events of the firm on the register: 11

Other events of the firm

Other FDA enforcement events of 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
6 Feb 2019	Oxytocin 10 Units added to NS 1000 mL (oxytocin and 0.9% Sodium Chloride) Injectable Solution, Approximately 1001 mL Ste	Drug	Class III	3
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

Advanced Pharma Inc.: all 11 events

Official channels

FDA enforcement report D-0794-2017The FDA record of the first product of this event.
FDA: recalls, market withdrawals and safety alertsThe recall notices on the FDA site.
FDA MedWatchThe FDA safety reporting program for drugs and medical devices.

Follow by RSS:Food, drug and device recallsFDA Class I recalls

Cite this page

Recall Register. FDA enforcement event 76561. https://recallregister.com/fda/ii/76561/. Source: openFDA enforcement reports. Data through 28 Sep 2026.

Sources

Source: openFDA drug enforcement reports
Licence: CC0 1.0
Export date: 28 Sep 2026
Newest FDA report date on the register: 23 Sep 2026

FDA has one record for each product. This site puts the records with the same event number on one page. The class of the event is the highest class of its records. How the register is made. Report an error.

Questions

Where was the product distributed?: The FDA record gives this distribution: U.S. Nationwide
How did the recall start?: The FDA record says: Voluntary: Firm initiated
How many drug recalls of 2017 have the same class?: 57% of the 343 drug events that started in 2017 are in Class II.
How many FDA recalls does Advanced Pharma Inc. have?: Advanced Pharma Inc. is the recalling firm in 11 enforcement events on this register. This event is 1 of them.