CLASS II Drug recall · Reported 25 Jul 2018 · FDA Enforcement Report
0.2% ROPivacaine, (Ropivacaine HCL PF, USP 500mg recalled
Avella of Deer Valley Inc. Store 38 is recalling 0.2% ROPivacaine, (Ropivacaine HCL PF, USP 500mg, 0.9% Sodium Chloride, USP QS. Volume, distributed nationwide in the US. The recall was initiated on 12 Jun 2018 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0942-2018
- FDA event ID
- 80307
- Recalling firm
- Avella of Deer Valley Inc. Store 38, Phoenix, AZ
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 12 Jun 2018
- FDA classified
- 19 Jul 2018
- Reported
- 25 Jul 2018
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Sterility
- Drug class
- Injectable & IV Drugs
Timeline
| 12 Jun 2018 | Recall initiated by company | |
| 19 Jul 2018 | Classified by FDA | +37 days |
| 25 Jul 2018 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Lack of Assurance of Sterility: Potential leakage of bags.
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
Product as listed by the FDA
0.2% ROPivacaine, (Ropivacaine HCL PF, USP 500mg, 0.9% Sodium Chloride, USP QS 250 mL). Volume 250 mL. Single dose Cassette. For: Parkland Memorial Hospital. By: Advanced Pharma, 9225 Kirby Dr. Houston, TX 77054. Parkland Memorial Hospital NDC 15082-002-87
Where it was distributed
Nationwide in the USA
Questions about this recall
Why was it recalled?
Lack of Assurance of Sterility: Potential leakage of bags.
Which lots are affected?
Lot 5/14/18 0722 47-00287Y EXP 06/28/2018
Where was it sold?
Nationwide in the USA
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
37 other products · FDA event 80307More recalls from Avella of Deer Valley Inc. Store 38
All 50| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Povidone Iodine, 5% Ophthalmic Solution per droptainer recalled | Avella of Deer Valley Inc. Store 38 | Sterility | Nationwide |
| Drug | CLASS II | Bevacizumab 2.5 mg recalled by Avella of Deer Valley, Inc. | Avella of Deer Valley Inc. Store 38 | Sterility | Nationwide |
| Drug | CLASS II | MAGnesium 2gm sulfate, added to D5W, Volume recalled | Avella of Deer Valley Inc. Store 38 | Other | 13 states |
| Drug | CLASS II | MAGnesium 1gm sulfate, added to D5W, Volume recalled | Avella of Deer Valley Inc. Store 38 | Other | 13 states |
| Drug | CLASS II | Labetalol 20mg, HCL, USP Injectable Solution, 20mg recalled | Avella of Deer Valley Inc. Store 38 | Packaging Defects | 13 states |
Other Ropivacaine recalls
All 14| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Naropin (ropivacaine hydrochloride Injection, USP) recalledNaropin | Fresenius Kabi USA | Particulate Matter | Nationwide |
| Drug | CLASS I | Ropivacaine Hydrochloride Injection, USP, 0.5%, 500 mg per (5mg/mL) recalledRopivacaine Hydrochloride | Amneal Pharmaceuticals | Particulate Matter | Nationwide |
| Drug | CLASS II | Ropivacaine Hydrochloride Injection USP, 0.5%, 150mg recalled by Akorn | Akorn | Potency & Assay | Nationwide |
| Drug | CLASS II | Ropivacaine Hydrochloride Injection USP, 0.2%, 200mg/ (2 mg/mL) Vial recalled | Akorn | Potency & Assay | Nationwide |
| Drug | CLASS II | Ropivacaine HCl 123 mg (2.46 mg/mL), Clonidine HCl 0.04 mg recalled | Nephron Sterile Compounding Center | Sterility | Nationwide |