The Recall Desk
HighFDA (Devices)·Z-1953-2015·Announced 2015-07-08

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.

What this means for you

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
Category
Medical Device — Personal Lubricant
Hazard
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

Distributed in 11 states:

Related recalls

Same hazard · b cepacia

See all →