RIFAMPIN for Injection,USP, 600 mg per vial, Rx Only, Manufactured by: Emcure Pharmaceuticals L...
FDA Drug Recall #D-0416-2015 — Class II — February 25, 2015
Recall Summary
| Recall Number | D-0416-2015 |
| Classification | Class II — Moderate risk |
| Date Initiated | February 25, 2015 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Heritage Pharmaceuticals, Inc. |
| Location | Eatontown, NJ |
| Product Type | Drugs |
| Quantity | 24,344 vials |
Product Description
RIFAMPIN for Injection,USP, 600 mg per vial, Rx Only, Manufactured by: Emcure Pharmaceuticals Ltd., Hinjwadi, Pune, India Manufactured for: Heritage Pharmaceuticals Inc., Eatontown, NJ 07724 NDC 23155-340-31
Reason for Recall
Lack of Assurance of Sterility: Firm is recalling two injectable products due to concerns with quality control processes.
Distribution Pattern
Nationwide
Lot / Code Information
Lot # VRIA002; Exp. 08/16, VRIA003; Exp. 09/16, VRIA004; Exp. 09/16
Other Recalls from Heritage Pharmaceuticals, Inc.
| Recall # | Classification | Product | Date |
|---|---|---|---|
| D-1397-2019 | Class I | PROCHLORPERAZINE EDISYLATE INJECTION, USP 10 mg... | May 21, 2019 |
| D-1398-2019 | Class I | AMIKACIN SULFATE INJECTION, USP, 1 gram/4 mL (2... | May 21, 2019 |
| D-1291-2019 | Class II | Losartan Potassium Tablets USP 25 mg 90 film co... | May 3, 2019 |
| D-1289-2019 | Class II | Losartan Potassium Tablets USP 50 mg 90 film co... | May 3, 2019 |
| D-1287-2019 | Class II | Losartan Potassium Tablets, USP 50 mg 1000 film... | May 3, 2019 |
Frequently Asked Questions
Injectable drugs and eye drops must be completely free of microbial contamination because they bypass the body's natural defenses. A contaminated injectable can introduce bacteria or fungi directly into the bloodstream, potentially causing sepsis, meningitis, or localized infections — all of which can be life-threatening. Contamination of sterile products almost always results in a Class I recall. If you received an injectable drug from a recalled lot, contact your healthcare provider immediately, even if you feel well, as some infections can have delayed onset.
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.