Recalls / Class III
Class IIID-0367-2021
Product
Acyclovir Tablets, USP, 400 mg, 100 Tablets, Rx Only, Distributed by: Avet Pharmaceuticals Inc., East Brunswick, NJ 08816, NDC 23155-227-01. Packaged in 150 cc white HDPE bottle
- Brand name
- Acyclovir
- Generic name
- Acyclovir
- Active ingredient
- Acyclovir
- Route
- Oral
- NDCs
- 23155-227, 23155-228
- FDA application
- ANDA074891
- Affected lot / code info
- Lot A120036, Exp DEC 2023
Why it was recalled
Labeling: Incorrect or Missing Lot and/or Exp Date
Recalling firm
- Firm
- Heritage Pharmaceuticals Inc
- Manufacturer
- Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 1 Tower Center Blvd Ste 1700, N/A, East Brunswick, New Jersey 08816-1145
Distribution
- Quantity
- 408 bottles
- Distribution pattern
- OH
Timeline
- Recall initiated
- 2021-04-21
- FDA classified
- 2021-05-06
- Posted by FDA
- 2021-05-12
- Terminated
- 2022-06-09
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0367-2021. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.