The Recall Desk
ModerateFDA (Drugs)·D-0693-2022·Announced 2022-03-30

Lidocaine Cream 4% Recalled Due to cGMP Deviations

Teligent Pharma is recalling all unexpired Lidocaine Cream 4% due to manufacturing quality deviations. The firm has discontinued its stability study program.

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: This is an FDA Class II recall involving manufacturing deviations related to discontinued stability studies. No illnesses or injuries are reported in the source text, and the hazard is procedural rather than involving a known contaminant or defect, making this a precautionary or compliance-driven recall.

Plain-English summary

Teligent Pharma, Inc. is recalling Lidocaine Cream 4% due to current Good Manufacturing Practice (cGMP) deviations. All products within expiry are affected by this recall because the firm is discontinuing its stability study program.

The recalled product is available in three package sizes: 15-gram tubes (NDC 52565-122-15), 30-gram tubes (NDC 52565-122-30), and 5 x 5-gram tubes (NDC 52565-122-07). A total of 136,960 tubes have been distributed nationwide in the USA and Puerto Rico.

Consumers who have this product should stop using it. Those with questions about the recall or the product should contact their healthcare provider or pharmacist for guidance.

The recalled product

Product
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 Jer
Manufacturer
Teligent Pharma, Inc.
Category
Drug — Topical Anesthetic
Hazard
  • cgmp-violation
  • stability-study-discontinuation

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 (17)

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

Distribution

Distributed nationwide across the United States.

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