Class II · Moderate risk
acyclovir sodium
Lack of Assurance of Sterility
Acyclovir Tablets
Class III — Low risk. Unlikely to cause harm, but violates FDA regulations.
Why it was recalled
Presence of Foreign Substance: human hair melded into tablet.
Cause type: Particulate / foreign matter
Visible foreign particles - glass, metal, fibers or other material - found in the product. Particles can enter from equipment wear, containers or the process, and are dangerous in injectables. All particulate / foreign matter recalls.
What was recalled
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
Affected NDC
31722-0778-01
Compare with the code on your package — it is the most precise check available.
Drug: Acyclovir
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 |
|---|---|---|---|---|
| Acyclovir NDC 31722-0778 |
800 mg/1 | Tablet Oral |
Camber Pharmaceuticals, Inc. | Rx |
- Recalling firm
- Hetero USA Inc
- NDC code
- 31722-778-01
- Origin
- NJ, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0897-2017 · FDA notice
Low risk, still worth a check. Class III means the product is unlikely to cause harm but breaks an FDA rule (often labeling). If your lot matches, your pharmacy will normally swap it; there is no need for alarm. This recall is now terminated, which means the firm has finished removing the affected product; anything on pharmacy shelves today should be unaffected.
Other Acyclovir recalls
See all
Class II · Moderate risk
Acyclovir Oral Suspension
CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Class II · Moderate risk
Acyclovir Sodium Injection 1
Presence of Particulate Matter: Customer complaint of dark particles found inside the vial
Class II · Moderate risk
Acyclovir Sodium Injection
Presence of Particulate Matter: Customer complaint for a dark red, brown and black particulate floating inside vial.
Class III · Low risk
Acyclovir Tablets
Labeling: Incorrect or Missing Lot and/or Exp Date
Other recalls by Hetero USA Inc
All 2017 recalls
Class II · Moderate risk
Pantoprazole Sodium Delayed Release Tablets USP 40mg
CGMP Deviations: Discoloration
Class II · Moderate risk
Entecavir Tablets 0.5 mg
Failed Impurities/Degradation Specification: single unknown impurity OOS 0.33% (Limit:NMT 0.20%W/W) at the three month stability point.
Class III · Low risk
Montelukast sodium tablets
Discoloration: the firm received a complaint of a sealed bottle in which tablets inside had blue spots and a blue powder inside the bottle.
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