Class II · Moderate risk
Naropin (ropivacaine hydrochloride Injection, USP)
Presence of Particulate Matter: Hair was found in products
ROPivacaine HCl 0.2% PF in Sodium Chloride 1
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
STAQ Pharma Inc. received consumer complaints related to leaking bags and other potential bag concerns. Upon investigation, they determine the source of the issue was with the bag manufacturer who released bags Lot # 134142-001A which had failed internal QC tests for leaks.
Cause type: Failed specification
A physical or chemical test other than potency, dissolution, impurity or stability failed - pH, viscosity, appearance, tablet integrity, fill volume. A product outside its own specification may not perform as designed, even if the active ingredient is present. All failed specification recalls.
What was recalled
ROPivacaine HCl 0.2% PF in Sodium Chloride 1,000 mg/500 mL (2 mg per mL) Injection, 500 mL bags, Rx only, STAQ Pharma Inc. 14135 E 42nd Ave, Unit 50, Denver, Colorado 80239, NDC 73177-0109-26,
Affected NDC
73177-0109-26
Compare with the code on your package — it is the most precise check available.
Drug: Ropivacaine
- Recalling firm
- STAQ Pharma, Inc.
- NDC code
- 73177-0109-26
- Origin
- CO, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0147-2024 · 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 completed, 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 STAQ Pharma, Inc.
All 2023 recalls
Class III · Low risk
FentaNYL Citrate PF
Labeling: Incorrect or Missing Lot and/or Exp Date
Class III · Low risk
Ketamine Hydrochloride
Labeling: Incorrect or Missing Lot and/or Exp Date
Class III · Low risk
Hydromorphone HCL PF
Labeling: Incorrect or Missing Lot and/or Exp Date
Class I · High risk
Morphine Sulfate PF 25 mg/25mL
Labeling: Label Mix up; A limited number of syringes containing HYDROmorphone HCl PF were incorrectly labeled as Morphine Sulfate PF with lot number 21104221A
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