Why it was recalled
Presence of Foreign Substance: human hair melded into tablet.
Product description
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
Lot numbers, UPCs & expiration codes
Lot # ACY16075 Exp. 09/2018
Where it was sold
Nationwide
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0897-2017
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- Apr 27, 2017
- FDA report date
- Jun 14, 2017
- Quantity
- 13,692 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Hetero USA Inc
Original FDA data
Every field from FDA enforcement report D-0897-2017, exactly as published.
Show all FDA fields
- City
- Piscataway
- State
- NJ
- Status
- Terminated
- Country
- United States
- Event ID
- 77122
- Address
- 1035 Centennial Ave
- Code information
- Lot # ACY16075 Exp. 09/2018
- Postal code
- 08854-4124
- Report date
- Jun 14, 2017
- Product type
- Drugs
- Recall number
- D-0897-2017
- Classification
- Class III
- Recalling firm
- Hetero USA Inc
- Product quantity
- 13,692 bottles
- Termination date
- Dec 13, 2017
- Reason for recall
- Presence of Foreign Substance: human hair melded into tablet.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- 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
- Distribution pattern
- Nationwide
- Recall initiation date
- Apr 27, 2017
- Initial firm notification
- Letter
- Center classification date
- Jun 7, 2017