Betamethasone Dipropionate Lotion USP, 0.05% (Augmented), 30 mL bottle, (29 g), Rx Only, Teligent Pharma Inc., Buena, NJ, 08310, NDC 52565-023-29

FDA recall notice · announced January 5, 2022 · Teligent Pharma

Class II FDA/FSIS Class II: use may cause temporary or medically reversible adverse health consequences.

The product

Betamethasone Dipropionate Lotion USP, 0.05% (Augmented), 30 mL bottle, (29 g), Rx Only, Teligent Pharma Inc., Buena, NJ, 08310, NDC 52565-023-29

Reason for recall

Failed Stability Specifications: lot did not meet specification for the Active Pharmaceutical Ingredient (API) particle test, which was determined through routine stability testing

Notes

Distribution: Distributed Nationwide in the USA
Lot/code information: Lot # 16569, Exp 9/2022
Quantity: 3,792 bottles
Status: Terminated
Products in this recall event:
- Betamethasone Dipropionate Lotion USP, 0.05% (Augmented), 30 mL bottle, (29 g), Rx Only, Teligent Pharma Inc., Buena, NJ, 08310, NDC 52565-023-29 (D-0297-2022)

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