Lidocaine/Tetracaine Ointment Recalled for Higher Concentration Than Listed
Stanley Specialty Pharmacy is recalling Lidocaine/Tetracaine ointment because the lidocaine concentration is higher than listed on the label.
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 recall is classified as FDA Class II, which corresponds to a Severe severity score under the rubric for significant injury or property damage reports or high-risk scenarios.
Plain-English summary
Stanley Specialty Pharmacy Compounding and Wellness Center is recalling Lidocaine/Tetracaine (LIPO110) 23%/7% Ointment. The recall is due to the lidocaine concentration being higher than the amount listed on the product label.
The affected product is a prescription-only ointment packaged in 4-ounce plastic jars. The specific lot number is 195789, with an expiration date of April 17, 2021. The total quantity involved is 4,400 grams, which corresponds to 44 jars.
The product was distributed nationwide in the United States. Consumers and healthcare providers should stop using the affected product and contact their pharmacist or physician for guidance on disposal or replacement.
The recalled product
- Product
- Lidocaine/Tetracaine (LIPO110)* 23%/7% Ointment 100 GMS per 4 ounce plastic ointment jar, Rx Only, Stanley Specialty Pharmacy 3120 Latrobe Dr. Suite 200 Charlotte, NC 28211
- Category
- Drug — Topical Anesthetic
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)
- Lot: 195789 Exp. Apr. 17 2021
Distribution
Distributed nationwide across the United States.
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