Sheffield Pharmaceuticals Recalls LUBRI GEL Due to B. cepacia Contamination
Sheffield Pharmaceuticals is recalling specific lots of Dr. Sheffield's LUBRI GEL personal lubricant after testing revealed high counts of gram-positive rods and B. cepacia.
The agency’s classification
FDA (Devices): 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 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a non-sterile medical device contaminated with B. cepacia, a high-risk pathogen. Per the rubric, high-risk pathogens without reported illness warrant a score of 3.
Plain-English summary
Sheffield Pharmaceuticals, LLC is recalling 37,636 units of Dr. Sheffield's LUBRI GEL 3 oz (85 g) non-sterile over-the-counter personal lubricant. The recall affects specific lots with expiration dates of 01/18, including lot numbers 40131, 40132, and 40141.
The recall was initiated because testing recovered a high count of gram-positive rods, including single colonies of B. cepacia. The product was distributed worldwide, including in the United States (CA, NJ, FL, PR, MI, NY, NC, IL, GA, MN, KS) and in Jamaica and Georgia.
Consumers should stop using the affected product and contact Sheffield Pharmaceuticals for further instructions or a refund. The source text does not report any illnesses or injuries associated with this recall.
The recalled product
- Product
- Dr. Sheffield's LUBRI GEL 3 oz (85 g) Non sterile over-the-counter personal lubricant.
- Manufacturer
- Sheffield Pharmaceuticals, LLC
- Affected units
- 37,636
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 (3)
- Lot Numbers: 40131 EXP 01/18
- 40132 EXP 01/18
- 40141 EXP 01 /18
Distribution
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