Lorazepam 2 mg/mL Inj., Qty: 1 mL Vial, MFG by: West-Ward Pharma, Eatontown, NJ 07724, Repackaged...
FDA Drug Recall #D-0515-2016 — Class II — November 11, 2015
Recall Summary
| Recall Number | D-0515-2016 |
| Classification | Class II — Moderate risk |
| Date Initiated | November 11, 2015 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | RemedyRepack Inc. |
| Location | Indiana, PA |
| Product Type | Drugs |
| Quantity | 1625 Vials |
Product Description
Lorazepam 2 mg/mL Inj., Qty: 1 mL Vial, MFG by: West-Ward Pharma, Eatontown, NJ 07724, Repackaged by: RemedyRepack Inc., 625 Kolter Dr., Indiana, PA 15701, NDC 61786-0316-01
Reason for Recall
Labeling: Incorrect Instructions; RemedyRepack, Inc. a relabeler, is recalling these products due to incorrect storage instructions.
Distribution Pattern
Nationwide
Lot / Code Information
LOT#: B0085124-051915, B0086919-052815, Exp 12/01/2016; B0089280-061215, B0090023-061915, B0089996-061915, B0091581-070715, B0091564-070715, B0091515-070715, Exp 01/01/2017; B0094980-080415, B0094965-080415, B0097515-082415, B0100639-091415, B0100611-091415, Exp 03/01/2017; B0100933-091515, B0107165-101915, B0107118-101915, Exp 06/01/2017.
Other Recalls from RemedyRepack Inc.
| Recall # | Classification | Product | Date |
|---|---|---|---|
| D-0411-2025 | Class II | Clindamycin HCl Capsule, 300 mg, QTY: 30 Capsul... | Apr 22, 2025 |
| D-0378-2025 | Class II | Clindamycin HCl, 300 mg Capsule, QTY: 30 Capsul... | Mar 24, 2025 |
| D-0217-2025 | Class II | Carvedilol 25 mg Tablet, QTY: 30 Tablets per Bl... | Jan 24, 2025 |
| D-0165-2025 | Class II | Duloxetine Delayed-Release Capsules, 60 mg, a) ... | Dec 2, 2024 |
| D-0611-2024 | Class II | Potassium Chloride Micro 10mEq K (750 mg) Exten... | Jun 26, 2024 |
Frequently Asked Questions
Stop using the medication immediately and contact your pharmacist. A mislabeling recall can range from a minor technical error (wrong font size) to a serious mix-up where one drug is inside another drug's packaging. If you received a medication that looks or acts differently than expected, or if you experienced unexpected effects, tell your doctor immediately. The pharmacist can verify whether your specific lot is affected and provide a replacement. Report any adverse effects experienced 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.