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.
The agency’s classification
FDA (Drugs): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
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 5/5 (Critical).
Highest-severity recall. The hazard can cause serious injury or death. 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.
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