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Recall Observatory FDA recall evidence

Drug product

Erythromycin Topical Gel, 2%, Net Wt. (a) 30 g,(NDC 52565-033-30) (b) 60 g,(NDC 52565-033-60) Rx Only, Manufactured by: Teligent Pharma, Inc. , Buena, NJ 08310,

D-0690-2021

June 22, 2021

Class III

Product summary

Firm
Teligent Pharma, Inc.
Event
Event 88145
Status
Terminated
Classification
Class III
Quantity
22,824 tubes
Official record key
drug-enforcement:D-0690-2021

Official wording

Reason: Failed Impurities/Degradation Specifications

Code information: 1) NDC 52565-033-30 Lot 14010, Exp July 2021; 2) NDC 52565-033-60 Lot 13865, Exp June 2021; Lot 14011, Exp July 2021.

Distribution pattern: Nationwide

Derived failure modes

  • Potency or specification failure

    reason.potency_specification_failure · v1.0.0

    Failed Impurities/Degradation Specifications