Product Safety Recalls

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ALLOPURINOL Recall D-0168-2023

Description: Allopurinol Tablets USP, 100 mg, 100-count bottle, Rx Only, Manufactured for: Accord Healthcare, Inc., Durham, NC 27703, Manufactured by: Intas Pharmaceuticals Limited, Pharmez, Ahmedabad-382 213. India. NDC 16729-134-01

ALLOPURINOL Recall D-0168-2023 Information

Mandated?Voluntary: Firm initiated
Recall NumberD-0168-2023
Event ID91499
Original Package?1
Active SubstanceALLOPURINOL
Drug RouteORAL
DistributionNationwide in the USA
Quantity87,576 bottles
Recall ReasonPresence of Foreign Substance: Presence of a small piece of green plastic embedded in the crack towards the edge of the tablet.
Drug ClassificationClass II
Drug Code Info20230201
Product NDC16729-134 16729-135
Product NUIN0000175698 N0000000206
Pharma Class (EPC)Xanthine Oxidase Inhibitor [EPC]
Recall Initiation Date20230112
Report Date20230201
Classification Date20230120
Address1009 Slater Rd Ste 210B
Durham, NC 27703-8446
United States
Recalling FirmAccord Healthcare, Inc.
Initial Notification Letter
Unique Ingredient Identifier63CZ7GJN5I
Drug Application NumberANDA203154
Structured Product Labeling (SPL ID)d10d00c1-a0d9-6fd8-e053-2a95a90a588a
Structured Product Labeling (SPL Set ID)682dd8b8-fc6e-47c5-95b7-82d7ad96b750
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