SCA Pharmaceuticals Recalls Lidocaine Syringes Due to Foreign Material
SCA Pharmaceuticals is recalling Lidocaine HCl 2% syringes because foreign material was found inside the vials.
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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The FDA classified this recall as Class II. According to the rubric, an FDA Class II recall with potential for adverse health consequences (foreign material in a drug) maps to a severity score of 4 (Severe), as it is not a Class I recall but involves a significant safety hazard.
Plain-English summary
SCA Pharmaceuticals, LLC is recalling 1,363 syringes of Lidocaine HCl 2% 5 mL. The recall was initiated because foreign material was found inside the vials.
The affected product is Lidocaine HCl 2% 5 mL, Syringe, Rx Only, with NDC 70004-0723-09. The specific lots involved are identified by codes 1219012595 (dated 29-Dec-19) and 1219012647 (dated 01-Jan-20). The product was distributed nationwide.
Consumers and healthcare providers should check their inventory for these specific lot codes and stop using the product if it matches the description. The FDA has classified this recall as Class II, indicating that use of or exposure to the product may cause temporary or medically reversible adverse health consequences.
The recalled product
- Product
- Lidocaine HCl 2% 5 mL, Syringe, Rx Only, SCA Pharmaceuticals 755 Rainbow Road Windsor, CT 08695 NDC 70004-0723-09
- Manufacturer
- SCA Pharmaceuticals, LLC
- Category
- Drug — Injectable
- Hazard
- Affected units
- 1,363
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 (1)
- 1219012595 29-Dec-19 1219012647 01-Jan-20
Distribution
Distributed nationwide across the United States.
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