The Recall Desk
CriticalFDA (Drugs)·D-0118-2021·Announced 2020-12-09

MPM Medical Recalls REGENECARE HA Topical Anesthetic Due to Bacteria

MPM Medical LLC is recalling REGENECARE HA topical anesthetic hydrogel because it was found to be contaminated with Burkholderia cepacia bacteria.

What this means for you

Highest-severity recall. Risk of serious injury or death is documented or strongly suspected. Stop using the product now and follow the agency's instructions.

Our severity reasoning: The recall is classified as FDA Class I, which meets the rubric criteria for a Critical severity score.

Plain-English summary

MPM Medical LLC is recalling 7,637 tubes of REGENECARE HA (Lidocaine HCL 2%) Topical Anesthetic Hydrogel. The product is identified by Lot 41262 with an expiration date of 01/21. The recall was initiated because the product was found to be contaminated with the bacteria Burkholderia cepacia.

The recalled product is a non-sterile drug product manufactured for MPM Medical LLC in Mesquite, TX. It was distributed nationwide in the USA. The specific product details include NDC 66977-107-03 and a net weight of 3 oz. (85 g).

Consumers should stop using the recalled product and contact MPM Medical LLC for further instructions or a refund. This recall is classified as Class I by the FDA, indicating a reasonable probability that use of the product could cause serious adverse health consequences or death.

The recalled product

Product
REGENECARE HA (LIDOCAINE HCL)
Brand
REGENECARE HA
Manufacturer
MPM Medical LLC
Category
Drug — Topical Anesthetic
Hazard
Affected units
7,637

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: 41262 Exp. 01/21

UPCs (1)

  • 0366977112055

Distribution

Distributed nationwide across the United States.

Related recalls

Same hazard · bacterial contamination

See all →