ROPivacaine HCl Injection Bags Recalled Due to Leaking
STAQ Pharma is recalling ROPivacaine HCl 0.2% injection bags nationwide due to leaking bags caused by manufacturing quality control failures. No illnesses or injuries have been reported.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This sterile injectable drug has compromised bag integrity, creating a risk of contamination or loss of sterility if administered. Although no illnesses or injuries have been reported, the recall is precautionary based on documented manufacturing defects, qualifying as a risk-of-harm product.
Plain-English summary
STAQ Pharma, Inc. is recalling 2,616 bags of ROPivacaine HCl 0.2% injection distributed nationwide. The company received consumer complaints about leaking bags and determined the source was a batch of bags from the bag manufacturer that failed internal quality control tests for leaks. Leaking bags could compromise product sterility and integrity if administered.
Healthcare providers and patients should stop using affected lots immediately and contact STAQ Pharma Inc. at 14135 E 42nd Ave, Unit 50, Denver, Colorado 80239 for further instructions. Affected lot numbers include: 23109472A, 23109473A, 23109474A, 23109491A, 23109492A, 23109501A, 23109520A, 23109521A, and 23109522A. Product NDC: 73177-0109-26.
The recalled product
- Product
- 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,
- Manufacturer
- STAQ Pharma, Inc.
- Category
- Drug — Injectable
- Hazard
- bag-leak
- contamination-risk
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (18)
- Lot#: 23109472A
- Exp. date 03/10/2024
- 23109473A
- Exp. date 03/11/2024
- 23109474A
- Exp. date 03/13/2024
- 23109491A
- Exp. date 03/16/2024
- 23109492A
- Exp. date 03/19/2024
- 23109501A
- Exp. date 03/25/2024
- 23109520A
- Exp. date 04/10/2024
- 23109521A
- Exp. date 04/13/2024
- 23109522A
- Exp. date 04/03/2024.
Distribution
Distributed nationwide across the United States.
Related recalls
Same category
- CriticalWarfarin Tablets Recalled After Mix-Up Between 2.5 mg and 5 mg Strengths
FDA (Drugs) · 2026-07-21
- ModerateFDA Recalls Pred Mild Ophthalmic Suspension Due to Failed Stability Specifications
FDA (Drugs) · 2026-06-03
- ModerateNicotine Transdermal System Patches Recalled for Oxidative Impurity Specification Failure
FDA (Drugs) · 2026-06-03
- ModerateGas-X Simethicone 125 mg softgels recall for incomplete labeling
FDA (Drugs) · 2026-05-27
- ModerateVitamin B-Complex, Vitamin C & Folic Acid Dietary Supplement Oral Liquid
FDA (Drugs) · 2026-05-27