CLASS II Drug recall · Reported 16 Sep 2015 · FDA Enforcement Report
Ropivacaine HCl 0.2% in total volume in a Yellow Cassette Res recalled
Pharmedium Services is recalling Ropivacaine HCl 0.2% in total volume in a Yellow Cassette Res, distributed in Idaho, Illinois, Pennsylvania, Virginia. The recall was initiated on 21 Jul 2015 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-1428-2015
- FDA event ID
- 71892
- Recalling firm
- Pharmedium Services, Lake Forest, IL
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 21 Jul 2015
- FDA classified
- 10 Sep 2015
- Reported
- 16 Sep 2015
- Type
- Voluntary: Firm initiated
- Customers notified by
- Telephone
- Reason category
- Sterility
- Drug class
- Injectable & IV Drugs
Timeline
| 21 Jul 2015 | Recall initiated by company | |
| 10 Sep 2015 | Classified by FDA | +51 days |
| 16 Sep 2015 | 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: The firm received a complaint of a sterility failure using a non-validated sterility test on a medication cassette.
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
Ropivacaine HCl 0.2% in 100 mL total volume in a 100 mL Yellow Cassette Res. Flowstop in Sodium Chloride 0.9%, Rx Only, PharMEDium Services, LLC, 6100 Global Drive, Memphis, TN 38141, NDC 61553-834-48
Where it was distributed
VA, IL, PA, ID
Questions about this recall
Why was it recalled?
Lack of Assurance of Sterility: The firm received a complaint of a sterility failure using a non-validated sterility test on a medication cassette.
Which lots are affected?
Lot #: 151900249M, Exp 09/09/15
Where was it sold?
VA, IL, PA, ID
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.
More recalls from Pharmedium Services
All 291| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | rocuronium Bromide, 10 mg per mL, 50 mg per BD Syringe recalled | PharMEDium Services | Sterility | Nationwide |
| Drug | CLASS II | ePHEDrine Sulfate, 5 mg per mL, 25 mg recalled by PharMEDium Services | PharMEDium Services | Sterility | Nationwide |
| Drug | CLASS II | fentaNYL Citrate 10 mcg per mL, 2,500 mcg per in a LifeCare recalled | PharMEDium Services | Sterility | Nationwide |
| Drug | CLASS II | nICARdipine HCl (0.1 mg/mL) 1 mg recalled by PharMEDium Services | PharMEDium Services | Sterility | Nationwide |
| Drug | CLASS II | rocuronium Bromide 10 mg per mL 50 mg per BD Syringe recalled | PharMEDium Services | Sterility | Nationwide |
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 |