The Recall Desk
ModerateFDA (Drugs)·D-0292-2019·Announced 2018-12-19

CAO Group Recalls BeeGentle Topical Anesthetic Due to cGMP Violations

CAO Group, Inc. is recalling BeeGentle Honey Flavored Topical Anesthetic because of current Good Manufacturing Practice (cGMP) violations found during a recent FDA inspection.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II due to cGMP violations, which typically indicates a risk of temporary or medically reversible adverse health consequences, fitting the Moderate severity criteria for voluntary precautionary recalls without reported serious injuries.

Plain-English summary

CAO Group, Inc. is voluntarily recalling BeeGentle Honey Flavored Topical Anesthetic, which contains 20% Benzocaine. The product is available in two formats: an Introductory Kit containing three 3cc preloaded syringes (NDC 1406000203) and a Bulk Kit containing 30mL (NDC 1406000202). The recall involves 803 units, consisting of 400 kits and 403 30mL bottles, which were distributed nationwide in the United States.

The recall was initiated due to current Good Manufacturing Practice (cGMP) violations noted during the firm's most recent inspection. The FDA has classified this recall as Class II, indicating that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

Consumers who have purchased this product should stop using it and contact CAO Group, Inc. for further instructions or a refund. The affected lots include specific expiration dates ranging from 2018 to 2020, as detailed in the recall notice.

The recalled product

Product
BeeGentle Honey Flavored Topical Anesthetic, Active ingredient Benzocaine 20%. Packaged in: a) Introductory Kit. Net Qty 3-3cc preloaded syringes. . NDC# 1406000203 UPC 8 72320 00074 5 b) Bulk Kit Net Qty 30mL, NDC# 1406000202, UPC 8 72320 00076 9. Manufactured by CAO (China) Me
Manufacturer
CAO Group, Inc.
Category
Drug — Topical Anesthetic
Hazard

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 (14)

  • Lots #: a) 110216
  • EXP 11/02/18
  • 170524
  • EXP 5/24/2019
  • 171116
  • EXP 11/16/2019
  • 180319
  • EXP 3/19/2020
  • b)110216
  • EXP 11/02/2018
  • 170323
  • EXP 3/23/2019
  • 180109
  • EXP 1/09/2020

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 4 recalled by CAO Group, Inc. under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 4 products in this recall →

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Same hazard · cGMP violations

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