Lidocaine Cream, 4%, packaged in a) Net Wt. 15 grams tubes, NDC 52565-122-15; b) Net Wt. 30 grams tubes, NDC 52565-122-30; c) 5 x 5 gram tubes, NDC 52565-122-07; Manufactured by: Teligent Pharma, Inc. Buena, New Jersey 08310; Manufactured by: Teligent Pharma, Inc., Buena, New Jersey 08310.

Class I - Dangerous
💊 Drugs Recalled: March 15, 2022 Teligent Pharma Other Drugs Nationwide

What Should You Do?

  1. Check if you have this product:
    Batch: a) 15192, Exp. 2/28/2022; 16278, Exp. 1/31/2023; b) 15124, 15192, Exp. 2/28/2022; 15296, 15336, 15337, 15439, Exp. 3/31/2022; 16278, Exp. 1/31/2023; 16603, 16664, Exp. 3/31/2023;17023, Exp. 6/30/2023; c) 15067, Exp. 2/28/2022; 16664, Exp. 3/31/2023
  2. Do not eat it: Even if it looks and smells fine, do not consume this product.
  3. Throw it away or return it: You can return the product to the store for a full refund.
  4. Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
  5. Report problems: Report any issues to the FDA's Safety Reporting Portal.

⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.

Recall Details

Company:
Teligent Pharma, Inc.
Reason for Recall:
cGMP deviations: all products within expiry are being recalled because the firm is discontinuing its stability study program.
Classification:
Class I - Dangerous

Dangerous or defective products that predictably could cause serious health problems or death.

Status:
terminated

Product Information

Full Description:

Lidocaine Cream, 4%, packaged in a) Net Wt. 15 grams tubes, NDC 52565-122-15; b) Net Wt. 30 grams tubes, NDC 52565-122-30; c) 5 x 5 gram tubes, NDC 52565-122-07; Manufactured by: Teligent Pharma, Inc. Buena, New Jersey 08310; Manufactured by: Teligent Pharma, Inc., Buena, New Jersey 08310.

Product Codes/Lot Numbers:

Batch: a) 15192, Exp. 2/28/2022; 16278, Exp. 1/31/2023; b) 15124, 15192, Exp. 2/28/2022; 15296, 15336, 15337, 15439, Exp. 3/31/2022; 16278, Exp. 1/31/2023; 16603, 16664, Exp. 3/31/2023;17023, Exp. 6/30/2023; c) 15067, Exp. 2/28/2022; 16664, Exp. 3/31/2023

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: D-0693-2022

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