Recalls / Class II
Class IID-0769-2021
Product
Erythromycin Topical Solution USP, 2%, 60mL bottle, Rx only, Teligent Pharma, Inc. Buena, NJ 08310, NDC 52565-027-59
- Affected lot / code info
- Lot #: 14892, Exp 1/2022
Why it was recalled
Defective container: possibility for lack of seal integrity.
Recalling firm
- Firm
- Teligent Pharma, Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 105 Lincoln Avenue, N/A, Buena, New Jersey 08310
Distribution
- Quantity
- 7488 bottles
- Distribution pattern
- USA Nationwide
Timeline
- Recall initiated
- 2021-07-29
- FDA classified
- 2021-08-25
- Posted by FDA
- 2021-09-01
- Status
- Ongoing
Source: openFDA Drug Enforcement endpoint. Recall record D-0769-2021. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.