NDC 52565-023
betamethasone dipropionate 0.5 mg per 1 mL lotion, augmented
On the label: Teligent Pharma, Inc..
Where it's made
| Factory | Where | Role | Last FDA inspection |
|---|---|---|---|
| Teligent Pharma, Inc. | Buena, New Jersey, United States | Makes it | Serious problems, FDA actionAug 31, 2021 · 8 inspections, 1 with FDA action |
Recalls
- Mar 15, 2022 · Class II · Teligent Pharma, Inc.
cGMP deviations: all products within expiry are being recalled because the firm is discontinuing its stability study program.
Lots: Batch: a) 15998, Exp. 3/31/2022; b) 16104, Exp. 4/30/2022; 16133, Exp. 5/31/2022; 16391, Exp. 8/31/2022; 15440, Exp. 9/30/2022 - Aug 23, 2021 · Class II · Teligent Pharma, Inc.
Failed Stability Specifications: lot did not meet specification for the Active Pharmaceutical Ingredient (API) particle test, which was determined through routine stability testing
Lots: Lot # 16569, Exp 9/2022
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.
Product details
- Generic drug
- Betamethasone: every company that makes it
- Form
- lotion, augmented
- Strength
- 0.5 mg per 1 mL
- Approval
- ANDA ANDA206389
- On the market since
- Feb 14, 2018
- Package NDCs
52565-023-2952565-023-59- Official label
- DailyMed (National Library of Medicine), updated May 22, 2018
Got it by mail or from a pharmacy you don't know? Look the pharmacy up on Who Filled My Rx?