Valganciclovir Tablets, USP, 450 mg, 60-count bottle, Rx Only, Manufactured for Camber Pharmace...
FDA Drug Recall #D-0601-2018 — Class II — February 13, 2018
Recall Summary
| Recall Number | D-0601-2018 |
| Classification | Class II — Moderate risk |
| Date Initiated | February 13, 2018 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Hetero Labs Limited Unit V |
| Location | Jadcherla Mandal, Mahaboob Nagar |
| Product Type | Drugs |
| Quantity | 1764 60-count bottles |
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
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).
Distribution Pattern
NJ and then distributed Nationwide in the USA
Lot / Code Information
Lot #s VGC17040 & VGC17041, EXP 07/2019
Other Recalls from Hetero Labs Limited Unit V
| Recall # | Classification | Product | Date |
|---|---|---|---|
| D-1213-2018 | Class II | Montelukast Sodium Tablets, 10 mg*, 30-count bo... | Aug 20, 2018 |
| D-0081-2019 | Class I | Montelukast Sodium Tablets 10 mg, 30-count bott... | Aug 15, 2018 |
| D-1116-2018 | Class II | Camber Pharmaceuticals, Inc. Valsartan Tablets,... | Aug 8, 2018 |
| D-1113-2018 | Class II | Camber Pharmaceuticals, Inc. Valsartan Tablets,... | Aug 8, 2018 |
| D-1115-2018 | Class II | Camber Pharmaceuticals, Inc. Valsartan Tablets,... | Aug 8, 2018 |
Frequently Asked Questions
Stop taking the medication and contact your pharmacist or doctor immediately. For Class I recalls, this is urgent. For Class II or III recalls, consult your doctor before stopping — abruptly discontinuing certain medications (blood pressure drugs, antidepressants, diabetes medications) can be more harmful than continuing while arranging a replacement. Check whether the recall applies to your specific lot number and expiration date. Return the product to your pharmacy and report any adverse effects to FDA MedWatch at 1-800-FDA-1088.
Not necessarily. Many drug recalls are initiated because of quality system failures or test results that suggest a product might not meet specifications — even if no patients have reported harm. The FDA uses a precautionary approach: if there is reason to believe quality standards were not met, a recall is required regardless of whether adverse effects have been reported. Class I recalls typically involve a reasonable probability of harm; Class II recalls may cause temporary health issues; Class III recalls are for products unlikely to cause adverse health consequences but that still violate regulations.
Pharmacies typically receive recall notices directly from drug wholesalers and manufacturers within days of the recall being announced. Your pharmacist can look up whether any product in your prescription history matches a recalled lot number. For current recalls, the FDA publishes updates at FDA.gov/safety/recalls-market-withdrawals-safety-alerts and sends MedWatch email alerts for significant drug safety issues. You can sign up for MedWatch alerts at FDA.gov. Most major pharmacy chains also have their own recall notification systems that automatically alert pharmacists when a recalled product is in their inventory.
What Should You Do?
Stop using this medication if affected by this recall. Contact your pharmacist or prescribing doctor immediately for guidance. Do not flush medications — use a drug take-back program.