Betamethasone Dipropionate Ointment USP, 0.05%* (Augmented), a) 15 gram (NDC 52565-019-15) and b) 50 gram (NDC 52565-019-51) tubed, Rx Only, Manufactured by: Teligent Pharma, Inc. Buena, New Jersey 06310

FDA recall notice · announced June 26, 2019 · Teligent Pharma

Class III FDA/FSIS Class III: use is not likely to cause adverse health consequences.

The product

Betamethasone Dipropionate Ointment USP, 0.05%* (Augmented), a) 15 gram (NDC 52565-019-15) and b) 50 gram (NDC 52565-019-51) tubed, Rx Only, Manufactured by: Teligent Pharma, Inc. Buena, New Jersey 06310

Reason for recall

Failed Impurities/Degradation Specifications

Notes

Distribution: Nationwide
Lot/code information: Lot 11852, exp date 08/2020
Quantity: 9360 tubes
Status: Terminated
Products in this recall event:
- Betamethasone Dipropionate Ointment USP, 0.05%* (Augmented), a) 15 gram (NDC 52565-019-15) and b) 50 gram (NDC 52565-019-51) tubed, Rx Only, Manufactured by: Teligent Pharma, Inc. Buena, New Jersey 06 (D-1391-2019)

Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.