Why it was recalled
Temperature Abuse: Valganciclovir Tablets USP 450 mg and Valacyclovir Tablets USP 1 gram were exposed to higher temperature at airport or cargo and in the same consignment of Famciclovir complaint batch (D-0415-2018).
Product description
Valganciclovir Tablets, USP, 450 mg, 60-count bottle, Rx Only, Manufactured for Camber Pharmaceuticals, Inc. Piscataway, NJ 08854, By: Hetero Hetero Labs Limit Unit V Pollypally Jadcherla Mahaboob Nagar - 509 301 India. NDC # 31722-832-60
Lot numbers, UPCs & expiration codes
Lot #s VGC17040 & VGC17041, EXP 07/2019
Where it was sold
NJ and then distributed 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-0601-2018
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Feb 13, 2018
- FDA report date
- Mar 21, 2018
- Quantity
- 1764 60-count bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Hetero Labs Limited Unit V
Original FDA data
Every field from FDA enforcement report D-0601-2018, exactly as published.
Show all FDA fields
- City
- Jadcherla Mandal, Mahaboob Nagar
- Status
- Terminated
- Country
- India
- Event ID
- 79142
- Address
- Unit V (SEZ Unit I in APIIC SEZ)
- Address (line 2)
- Surv. No. 439-441, 458, Polepally Vill.
- Code information
- Lot #s VGC17040 & VGC17041, EXP 07/2019
- Report date
- Mar 21, 2018
- Product type
- Drugs
- Recall number
- D-0601-2018
- Classification
- Class II
- Recalling firm
- Hetero Labs Limited Unit V
- Product quantity
- 1764 60-count bottles
- Termination date
- Feb 18, 2021
- Reason for recall
- Temperature Abuse: Valganciclovir Tablets USP 450 mg and Valacyclovir Tablets USP 1 gram were exposed to higher temperature at airport or cargo and in the same consignment of Famciclovir complaint batch (D-0415-2018).
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Valganciclovir Tablets, USP, 450 mg, 60-count bottle, Rx Only, Manufactured for Camber Pharmaceuticals, Inc. Piscataway, NJ 08854, By: Hetero Hetero Labs Limit Unit V Pollypally Jadcherla Mahaboob Nagar - 509 301 India. NDC # 31722-832-60
- Distribution pattern
- NJ and then distributed Nationwide in the USA
- Recall initiation date
- Feb 13, 2018
- Initial firm notification
- Letter
- Center classification date
- Mar 16, 2018