CLASS II Drug recall · Reported 18 Jul 2018 · FDA Enforcement Report
Buffered Lidocaine 1% with Sodium Bicarbonate Injection recalled
SCA Pharmaceuticals is recalling Buffered Lidocaine 1% with Sodium Bicarbonate Injection for Local Anesthetic Use. The recall was initiated on 29 Jun 2018 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-0918-2018
- FDA event ID
- 80425
- Recalling firm
- SCA Pharmaceuticals, Little Rock, AR
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 29 Jun 2018
- FDA classified
- 12 Jul 2018
- Reported
- 18 Jul 2018
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
- Drug class
- Pain Medication
Timeline
| 29 Jun 2018 | Recall initiated by company | |
| 12 Jul 2018 | Classified by FDA | +13 days |
| 18 Jul 2018 | 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
Subpotent Drug: Stability data does not support the current expiration dating of 55 days after compounding.
Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.
Product as listed by the FDA
Buffered Lidocaine 1% with Sodium Bicarbonate Injection for Local Anesthetic Use (Concentration=10 mg/mL) 0.25 mL Total Volume, Rx only , SCA Pharmaceuticals, 8821 Knoedl Ct. Little Rock, AR 72205 877-550-5059
Where it was distributed
United States
Questions about this recall
Why was it recalled?
Subpotent Drug: Stability data does not support the current expiration dating of 55 days after compounding.
Which lots are affected?
Lot #: 20180507@21, Exp 7/1/2018; 20180511@9, 20180511@24, Exp 7/5/2018; 20180518@24, 20180518@31, 20180518@32, Exp 7/12/2018; 20180531@21, Exp 7/25/2018; 20180601@11, Exp 7/26/2018
Where was it sold?
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.
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 Buffered Lidocaine recalls
All 2| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Buffered Lidocaine HCl, 1% (10mg/mL) recalled by SCA Pharmaceuticals | SCA Pharmaceuticals | Sterility | Nationwide |