Product Safety Recalls

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PENICILLAMINE Recall D-0148-2024

Description: Penicillamine Tablets USP 250 mg, 100-count bottle, Rx Only, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, MD 21202 Manufactured by: Lupin Limited, Nagpur-441 108, India, NDC# 70748-153-01

PENICILLAMINE Recall D-0148-2024 Information

Mandated?Voluntary: Firm initiated
Recall NumberD-0148-2024
Event ID93482
Original Package?1
Drug RouteORAL
DistributionProduct was distributed to 3 wholesale/distributor accounts.
Recall ReasonFailed Dissolution Specifications
Drug ClassificationClass II
Drug Code Info20231220
Product NDC70748-153
Product NUIN0000175713
Drug UPC0370748153017
Pharma Class (EPC)Antirheumatic Agent [EPC]
Recall Initiation Date20231122
Report Date20231220
Classification Date20231213
AddressHarborplace Tower111 S Calvert St Fl 21st
Baltimore, MD 21202-6174
United States
Recalling FirmLupin Pharmaceuticals Inc.
Initial Notification Letter
Unique Ingredient IdentifierGNN1DV99GX
Drug Application NumberANDA212933
Structured Product Labeling (SPL ID)99f3ca78-1663-47a1-9ed3-9c4eaa9f0271
Structured Product Labeling (SPL Set ID)f6ecaf47-902f-4378-b524-7a88f20ba138
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