Recalls / Class III
Class IIID-0897-2017
Product
Acyclovir Tablets, USP, 800 mg, 100-count bottle, Rx Only, Manufactured for: Camber Pharmaceuticals, Inc., Piscataway, NJ 08854, by Hetero Labs Limited, Unit V, Polepally, Jadcherla, Mahaboob Nagar - 509 301, India, NDC 31722-778-01
- Brand name
- Acyclovir
- Generic name
- Acyclovir
- Active ingredient
- Acyclovir
- Route
- Oral
- NDCs
- 31722-777, 31722-778
- FDA application
- ANDA203834
- Affected lot / code info
- Lot # ACY16075 Exp. 09/2018
Why it was recalled
Presence of Foreign Substance: human hair melded into tablet.
Recalling firm
- Firm
- Hetero USA Inc
- Manufacturer
- Camber Pharmaceuticals, Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 1035 Centennial Ave, N/A, Piscataway, New Jersey 08854-4124
Distribution
- Quantity
- 13,692 bottles
- Distribution pattern
- Nationwide
Timeline
- Recall initiated
- 2017-04-27
- FDA classified
- 2017-06-07
- Posted by FDA
- 2017-06-14
- Terminated
- 2017-12-13
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0897-2017. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.