Class II · Moderate risk
Ganciclovir
Lack of sterility assurance
Valganciclovir Tablets
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
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).
Cause type: Temperature excursion
The product was stored or shipped outside its labeled temperature range. Heat or freezing can degrade a drug without any visible change, so it may be weaker than labeled. All temperature excursion recalls.
What was recalled
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
Affected NDC
31722-0832-60
Compare with the code on your package — it is the most precise check available.
Drug: Ganciclovir
Product details
From the FDA NDC directory, for the product code this recall names. Compare with the label on your package.
| Product | Strength | Form & route | Labeler | Type |
|---|---|---|---|---|
| Valganciclovir NDC 31722-0832 |
HYDROCHLORIDE 450 mg/1 | Tablet, Film Coated Oral |
Camber Pharmaceuticals, Inc. | Rx |
- Recalling firm
- Hetero Labs Limited Unit V
- NDC code
- 31722-832-60
- Origin
- India
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0601-2018 · FDA notice
Check, then ask. Class II means harm is possible but usually temporary or reversible. Find the lot number on your package; if it matches, ask your pharmacist about a replacement. Do not simply stop a prescribed medication on your own - the gap can be riskier than the recall. This recall is now terminated, which means the firm has finished removing the affected product; anything on pharmacy shelves today should be unaffected.
Other Ganciclovir recalls
See all
Class II · Moderate risk
Ganciclovir for Injection
Labeling: Label mix-up - one vial was mislabeled as Cladribine Injection 10mg/mL inside a 10-count carton of Ganciclovir 500 mg.
Class II · Moderate risk
GANCICLOVIR in NS
Lack of Assurance of Sterility: Product sterility cannot be guaranteed.
Class II · Moderate risk
Ganciclovir Sodium
Lack of Assurance of Sterility: Sterility of product is not assured.
Class II · Moderate risk
Ganciclovir
Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection.
Other recalls by Hetero Labs Limited Unit V
All 2018 recalls
Class II · Moderate risk
Pantoprazole Sodium
Discoloration: Firm received five (5) complaints stating that, "Tablets discolored darker than normal and have lighter-colored spots."
Class II · Moderate risk
Losartan Potassium Tablets USP
Failed Tablet/Capsule Specification; complaint of bulging tablet
Class II · Moderate risk
Montelukast Sodium Tablets
Discoloration: A complaint was received from a pharmacist for the presence of blue specks on tablets.
Class I · High risk
Montelukast Sodium Tablets 10 mg
Labeling: Label Mix-Up - One lot labeled Montelukast Sodium Tablets 10 mg tablets may contain 90 tablets of Losartan Potassium 50 mg.
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