Ketorolac Trom 30 mg/mL Injection, packaged in a) 1 mL vials, NDC 61786-0741-01 (Orig: 00548-9021...
FDA Drug Recall #D-1176-2017 — Class II — August 22, 2017
Recall Summary
| Recall Number | D-1176-2017 |
| Classification | Class II — Moderate risk |
| Date Initiated | August 22, 2017 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | RemedyRepack Inc. |
| Location | Indiana, PA |
| Product Type | Drugs |
| Quantity | 40 vials |
Product Description
Ketorolac Trom 30 mg/mL Injection, packaged in a) 1 mL vials, NDC 61786-0741-01 (Orig: 00548-9021-00), Ref: 33631 and b) 10 x 1 mL vials per tray, NDC 61786-0741-08 (Orig: 00548-9021-00), Ref: 33632, Rx only, Packaged by: RemedyRepack Inc, Indiana, PA 15704; Mfg by: Amphastar, Rancho Cucamonga, CA 91730.
Reason for Recall
Crystallization: Product is being recalled due to the manufacturer's recall due to the presence of visible particulate in vials that has been identified as crystalline ketorolac calcium salt.
Distribution Pattern
Product was distributed to one consignee in Louisiana.
Lot / Code Information
Lot #: a) B0158730-060816 (Mfg: XI002A6), Exp: 12/2017 ; and b) B0160669-061516 (Mfg: XI003A6), Exp 12/2017
Other Recalls from RemedyRepack Inc.
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|---|---|---|---|
| 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 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.