FDA Recall D-0769-2021
Teligent Pharma, Inc. · Buena, NJ
Class II Ongoing 1750 days on record
Moderate impact — Class II recall — temporary or medically reversible adverse health consequence possible; remote probability of serious adverse health consequence.
Product
Erythromycin Topical Solution USP, 2%, 60mL bottle, Rx only, Teligent Pharma, Inc. Buena, NJ 08310, NDC 52565-027-59
Reason for recall
Defective container: possibility for lack of seal integrity.
Recall record
- Recall number
D-0769-2021- Classification
- Class II
- Status
- Ongoing
- Voluntary or mandated
- Voluntary: Firm initiated
- Firm notification
- Letter
- Distribution
- USA Nationwide
- Recall initiated
- 2021-07-29
- Classified by FDA Center
- 2021-08-25
- FDA published
- 2021-09-01
- Recalling firm
- Teligent Pharma, Inc.
- Firm location
- Buena, NJ
Operational response
Class II recalls indicate possible temporary or reversible health consequences. Remove affected lots from active dispensing. Segregate inventory. Check the firm’s recall notification for guidance on patient outreach.
For the official FDA enforcement record, see FDA's Recall Search.