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Recall Observatory FDA recall evidence

Drug product

Erythromycin Topical Solution USP, 2% 60 mL, Rx Only, Teligent Pharma, Inc., Buena, NJ 08310, NDC 52565-027-59

D-0689-2021

June 22, 2021

Class III

Product summary

Firm
Teligent Pharma, Inc.
Event
Event 88145
Status
Terminated
Classification
Class III
Quantity
7872 tubes
Official record key
drug-enforcement:D-0689-2021

Official wording

Reason: Failed Impurities/Degradation Specifications

Code information: Lot 14180

Distribution pattern: Nationwide

Derived failure modes

  • Potency or specification failure

    reason.potency_specification_failure · v1.0.0

    Failed Impurities/Degradation Specifications