Why it was recalled
Temperature Abuse: Complaints of tablets being wet and stuck together with tablet coating peeled and disintegrated as a result of prolonged exposure to high temp during distribution.
Product description
Famciclovir Tablets, 500 mg, 30-count bottles, Rx Only, Manufactured For: Camber Pharmaceuticals. Inc. Piscataway, NJ 08854 By: HETERO, Hetero Labs Limited, Unit V, Polepally, Jadcherla, Mahaboob Nagar-509 301, India. NDC 31722-708-30
Lot numbers, UPCs & expiration codes
Lot # FMC17039, Exp 07/2019.
Where it was sold
Nationwide in the USA.
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-0415-2018
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Dec 22, 2017
- FDA report date
- Feb 21, 2018
- Quantity
- 8,436 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Hetero Labs Limited Unit V
Original FDA data
Every field from FDA enforcement report D-0415-2018, exactly as published.
Show all FDA fields
- City
- Jadcherla Mandal, Mahaboob Nagar
- Status
- Terminated
- Country
- India
- Event ID
- 78811
- Address
- Unit V (SEZ Unit I in APIIC SEZ)
- Address (line 2)
- Surv. No. 439-441, 458, Polepally Vill.
- Code information
- Lot # FMC17039, Exp 07/2019.
- Report date
- Feb 21, 2018
- Product type
- Drugs
- Recall number
- D-0415-2018
- Classification
- Class II
- Recalling firm
- Hetero Labs Limited Unit V
- Product quantity
- 8,436 bottles
- Termination date
- Feb 5, 2020
- Reason for recall
- Temperature Abuse: Complaints of tablets being wet and stuck together with tablet coating peeled and disintegrated as a result of prolonged exposure to high temp during distribution.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Famciclovir Tablets, 500 mg, 30-count bottles, Rx Only, Manufactured For: Camber Pharmaceuticals. Inc. Piscataway, NJ 08854 By: HETERO, Hetero Labs Limited, Unit V, Polepally, Jadcherla, Mahaboob Nagar-509 301, India. NDC 31722-708-30
- Distribution pattern
- Nationwide in the USA.
- Recall initiation date
- Dec 22, 2017
- Initial firm notification
- Letter
- Center classification date
- Feb 15, 2018