Class II · Moderate risk
Naropin (ropivacaine hydrochloride Injection, USP)
Presence of Particulate Matter: Hair was found in products
Ropivacaine HCl 2 mg/mL 400 mL. Rx Only. Packaged in a ON-Q Pump…
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
Lack of sterility assurance.
Cause type: Sterility / contamination
A product that must be sterile could not be assured sterile, or was contaminated. A top reason for injectables, eye drops and IV products - loss of sterility assurance can lead to serious infections. All sterility / contamination recalls.
What was recalled
Ropivacaine HCl 2 mg/mL 400 mL. Rx Only. Packaged in a ON-Q Pump. Compounded Guardian Pharmacy Services, 7920 Elmbrook Dr. Ste. 108C Dallas TX 75247
Drug: Ropivacaine
- Recalling firm
- Guardian Pharmacy Services
- Origin
- TX, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-1064-2018 · FDA notice
Check, then ask. Class II means harm is possible but usually temporary or reversible. Find the lot number on your package; if it matches, ask your pharmacist about a replacement. Do not simply stop a prescribed medication on your own - the gap can be riskier than the recall. This recall is now terminated, which means the firm has finished removing the affected product; anything on pharmacy shelves today should be unaffected.
Other Ropivacaine recalls
See all
Class II · Moderate risk
R.E.C.K.
Presence of Particulate Matter
Class II · Moderate risk
Fentanyl citrate
CGMP Deviations: Revised interpretation of Acceptable Quality Level (AQL) results.
Class I · High risk
Ropivacaine Hydrochloride Injection
Presence of Particulate Matter
Class II · Moderate risk
FentaNYL 500mcg
Lack of Assurance of Sterility
Other recalls by Guardian Pharmacy Services
All 2018 recalls
Class II · Moderate risk
Phenol 6% with Glycerin Inj 10 ml. Packaged in 10 ml vials…
Lack of sterility assurance.
Class II · Moderate risk
MIC "B" COMBO LIPOTROPIC 50 ml. Packaged in a 50ml MDV vial…
Lack of sterility assurance.
Class II · Moderate risk
Methylcobalamin 1000 mcg/mL 100 mL. RX Only. Packaged in 100ml…
Lack of sterility assurance.
Class II · Moderate risk
Glutathione 200 mg/mL 50 ml MDV. Rx Only. Packaged in 50 mL…
Lack of sterility assurance.
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