CLASS II Drug recall · Reported 11 May 2022 · FDA Enforcement Report
Fentanyl 2mcg/ml and Bupivacaine 0.125% in 0.9% Sodium Chloride recalled
SCA Pharmaceuticals is recalling Fentanyl 2mcg/ml and Bupivacaine 0.125% in 0.9% Sodium Chloride, distributed nationwide in the US. The recall was initiated on 25 Apr 2022 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-0830-2022
- FDA event ID
- 90080
- Recalling firm
- SCA Pharmaceuticals, Windsor, CT
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 25 Apr 2022
- FDA classified
- 2 May 2022
- Reported
- 11 May 2022
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Manufacturing (CGMP) Deviations
- Drug class
- Pain Medication
Timeline
| 25 Apr 2022 | Recall initiated by company | |
| 2 May 2022 | Classified by FDA | +7 days |
| 11 May 2022 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
CGMP Deviations
Product as listed by the FDA
Fentanyl 2mcg/ml and Bupivacaine 0.125% in 0.9% Sodium Chloride 100 mL bags, Rx only, SCA Pharmaceuticals Windsor, CT 06095, NDC 70004-0231-32
Where it was distributed
Product was distributed nationwide within the United States
Questions about this recall
Why was it recalled?
CGMP Deviations
Which lots are affected?
Lot #: 1222035837, Exp. Date 22-Jul-22 Lot #: 1222035804, Exp. Date 25-Jul-22
Where was it sold?
Product was distributed nationwide within the United States
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
2 other products · FDA event 90080This product is part of a recall event; the main page for the event is Vancomycin HCl in 0.9% Sodium Chloride recalled by SCA Pharmaceuticals.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Vancomycin HCl in 0.9% Sodium Chloride recalled by SCA Pharmaceuticals | SCA Pharmaceuticals | Manufacturing (CGMP) Deviations | Nationwide | |
| CLASS II | Norepinephrine 8mg in 0.9% Sodium Chloride recalled | SCA Pharmaceuticals | Manufacturing (CGMP) Deviations | Nationwide |
More recalls from SCA Pharmaceuticals
All 166| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | fentaNYL 200 mcg/, Bupivacaine HCl recalled by SCA Pharmaceuticals | SCA Pharmaceuticals | Sterility | Nationwide |
| Drug | CLASS II | fentaNYL 2,500 mcg/ Injection (Concentration = 50 mcg/mL) recalled | SCA Pharmaceuticals | Sterility | Nationwide |
| Drug | CLASS II | PHENYLephrine HCl 500 mcg/ in 0.9% Sodium Chloride recalled | SCA Pharmaceuticals | Sterility | Nationwide |
| Drug | CLASS II | SUCcinylcholine Chloride 200 mg/ Injection recalled | SCA Pharmaceuticals | Sterility | Nationwide |
| Drug | CLASS II | PHENYLephrine HCl 500 mcg/ in 0.9% Sodium Chloride recalled | SCA Pharmaceuticals | Sterility | Nationwide |
Other Fentanyl recalls
All 248| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | fentaNYL Citrate, 1,000 mcg recalled by OurPharma | OurPharma | Other | Nationwide |
| Drug | CLASS II | fentaNYL Citrate, Sterile CADD for Injection, 2,2500 mcg recalled | IntegraDose Compounding Services | Potency & Assay | Nationwide |
| Drug | CLASS II | fentaNYL Citrate Injectable Solution recalled by Wells Pharma of Houston | Wells Pharma of Houston | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | fentaNYL Citrate Injectable Solution, Narcotic, CII recalled | Wells Pharma of Houston | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | fentaNYL Citrate Injectable Solution, Narcotic, Cii recalled | Wells Pharma of Houston | Manufacturing (CGMP) Deviations | Nationwide |