Published recall report · ImpurityUpdated · 1 yr 5 mo ago
Breckenridge Pharmaceutical, Inc recall: Duloxetine Delayed-Release Capsules USP, 60 mg, 1000-count bottles, Rx Only, Manufactured by Towa Pharmaceutical Europe, S.L., Distributed by Breckenridge Pharmaceutical, Inc. Berkeley Heights, NJ 07922, NDC# 51991-748-10
Duloxetine Delayed-Release Capsules USP, 60 mg, 1000-count bottles, Rx Only, Manufactured by Towa Pharmaceutical Europe, S.L., Distributed by Breckenridge Pharmaceutical, Inc. Berkeley Heights, NJ 07922, NDC# 51991-748-10
Current recall status is unverified. FDA does not update drug-enforcement status after publication. Check the latest official information or ask a pharmacist.
What to do
Check the lot number on your pack against this recall and follow the firm's instructions. Do not stop taking a prescribed medicine without talking to a pharmacist or doctor first.
FDA public enforcement report, opens in a new tabWhich products
Duloxetine Delayed-Release Capsules USP, 60 mg, 1000-count bottles, Rx Only, Manufactured by Towa Pharmaceutical Europe, S.L., Distributed by Breckenridge Pharmaceutical, Inc. Berkeley Heights, NJ 07922, NDC# 51991-748-10
- Producer
- Breckenridge Pharmaceutical, Inc
- Brand
- DULOXETINE
240987C
- Dates on pack
- Lot # 240987C, exp. date 04/2027 241014C, exp. date 04/2027
More detail
CGMP Deviations: Presence of Nitrosamine Drug Substance Related Impurity above the proposed interim limit.
In the news
Reporting from news publishers. Follow the official notice for product advice.
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