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Duloxetine capsules distributed by Breckenridge Pharmaceutical, Inc. have been recalled
On May 4, 2024, the U.S. Food and Drug Administration (FDA) reported that Breckenridge Pharmaceutical, Inc., (Breckenridge) issued a retail level recall of duloxetine delayed-release capsules.
This recall was initiated due to the presence of Nitrosamine Drug Substance Related Impurity (NDSRI), N-nitroso-duloxetine, above the proposed interim limit. According to the FDA, low levels of nitrosamines are found in water as well as dairy products, meats, and vegetables. These impurities may increase the risk of cancer if humans are exposed to them above acceptable levels over extended periods of time.
To date, Breckenridge has not published any reports of adverse events related to this recall.
The following batch numbers, distributed nationwide to pharmacies, are included in this recall.
| Medication Description | National Drug Code (NDC) | Batch Number (Expiration Date) |
|---|---|---|
| Duloxetine Delayed-Release Capsules 20 mg, 500-count bottle | 51991-0746-05 | 220456 (Exp. Feb 2025) |
| Duloxetine Delayed-Release Capsules 30 mg, 90-count bottle | 51991-0747-90 | 220265 (Exp. Feb 2025) 220088 (Exp. Nov 2024) 220267 (Exp. Feb 2025) |
| Duloxetine Delayed-Release Capsules 30 mg, 1000-count bottle | 51991-0747-10 | 220256 (Exp. Feb 2025) 220225 (Exp. Jan 2025) 220269 (Exp. Jan 2025) |
| Duloxetine Delayed-Release Capsules 60 mg, 90-count bottle | 51991-0748-90 | 230028C (Exp. Nov 2025) 230106C (Exp. Dec 2025) 230170C (Exp. Dec 2025) 220039 (Exp. Dec 2024) 220363 (Exp. Feb 2025) |
Impact on workers’ compensation and auto no-fault
Duloxetine (generic for Cymbalta®) is a serotonin-norepinephrine reuptake inhibitor (SNRI) antidepressant FDA-approved to treat depression, generalized anxiety disorder, painful diabetic neuropathy, fibromyalgia, and chronic musculoskeletal pain, including chronic low back pain and chronic pain due to osteoarthritis. It is also commonly prescribed off-label to treat chronic neuropathic pain.
Upon review of our transactional data, there was significant utilization of duloxetine capsules with these NDC numbers. However, this does not necessarily mean all injured persons in our book of business received one of the batch numbers listed in this recall.
As a general practice, pharmacies should not dispense recalled products and may contact injured persons when they receive notification about a recall. Batch or lot numbers may be tracked by the dispensing pharmacy but are not always displayed on the prescription bottle.
Injured persons who want to know if they received any of these batch numbers should contact their pharmacy, or their prescriber to discuss the use of duloxetine. Duloxetine should not be stopped abruptly. Furthermore, since duloxetine has been on the market for years, pharmacies most likely have duloxetine capsules in stock from other manufacturers and distributors.
If you have any questions, please contact your account manager, clinical liaison, or our Clinical Services team at 1-877-275-7674 ext. 8612.
Sources:
- U.S. Food and Drug Administration (FDA). Enforcement Report. Event ID 94483. Posted on May 4, 2024. Available at:https://www.accessdata.fda.gov/scripts/ires/?Event=94483. Accessed on May 6, 2024.
- California State Board of Pharmacy. Product recall: Breckenridge Pharmaceutical, Inc. – Duloxetine Delayed-Release Capsules. Available at: https://www.pharmacy.ca.gov/about/recall_alerts/050124_breckenridge.pdf. Accessed on May 6, 2024.
- U.S. Food and Drug Administration (FDA). FDA’s Role in Drug Recalls. September 29, 2023. Available at: https://www.fda.gov/drugs/drug-recalls/fdas-role-drug-recalls. Accessed on May 6, 2024.
