Product Safety Recalls

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DOXYCYCLINE Recall D-0178-2024

Description: Doxycycline Capsules, USP 100 mg, 50 Capsules, Rx Only, Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore, Maryland 21202 Unite States; Manufactured by: Lupin Limited, Nagpur - 441 108, INDIA. NDC 68180-652-08

DOXYCYCLINE Recall D-0178-2024 Information

Mandated?Voluntary: Firm initiated
Recall NumberD-0178-2024
Event ID89450
Original Package?1
Active SubstanceDOXYCYCLINE
Drug RouteORAL
DistributionNationwide USA
Quantity1 unit
Recall ReasonCGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.
Drug ClassificationClass II
Drug Code Info20240103
Product NDC68180-650 68180-651 68180-652
Product NUIN0000175882 N0000007948
Drug UPC0368180652083 0368180650010
Pharma Class (EPC)Tetracycline-class Drug [EPC]
Pharma Class (CS)Tetracyclines [Chemical/Ingredient]
Recall Initiation Date20220126
Report Date20240103
Classification Date20231226
Address7200 Cardinal Pl W
Dublin, OH 43017-1094
United States
Initial Notification Letter
Unique Ingredient IdentifierN12000U13O
Drug Application NumberANDA204234
Structured Product Labeling (SPL ID)16f7a4ab-b0e6-4429-b586-fb5e9dd7314a
Structured Product Labeling (SPL Set ID)bcc65910-30d8-4807-ab61-607a56382924
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