SCA Pharmaceuticals Recalls Subpotent Buffered Lidocaine Injection
SCA Pharmaceuticals is recalling 3,984 syringes of Buffered Lidocaine 1% Injection because stability data does not support the current expiration dating.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, which typically indicates a situation where use of the product may cause temporary or medically reversible health consequences. The hazard is a lack of potency (subpotent drug) due to stability issues, which is a significant quality defect but does not involve acute toxicity or immediate life-threatening injury in the same manner as contaminated or mislabeled allergens.
Plain-English summary
SCA Pharmaceuticals is recalling 3,984 syringes of Buffered Lidocaine 1% with Sodium Bicarbonate Injection for Local Anesthetic Use. The product is a prescription-only medication with a total volume of 0.25 mL and a concentration of 10 mg/mL. The recall covers specific lots with expiration dates ranging from July 1, 2018, to July 26, 2018.
The recall was initiated because the product is subpotent. According to the source text, stability data does not support the current expiration dating of 55 days after compounding. This means the medication may not maintain its intended potency throughout the labeled expiration period.
The affected product was distributed in the United States. Consumers and healthcare providers should stop using the recalled syringes and contact SCA Pharmaceuticals at 877-550-5059 for further instructions or a refund.
The recalled product
- Product
- 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
- Manufacturer
- SCA Pharmaceuticals
- Category
- Drug — Injection
- Affected units
- 3,984
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 (13)
- 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
Distribution
Distribution scope not specified by the agency.
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