Product Safety Recalls

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PREDNISONE Recall D-1330-2022

Description: Prednisone Tablets USP, 20 mg, 100-count bottle, Rx Only, Manufactured by: Strides Pharma Science Ltd., Bengaluru - 562106, India, Distributed by: Strides Pharma Inc., East Brunswick, NJ 08816, NDC 64380-785-06.

PREDNISONE Recall D-1330-2022 Information

StatusOngoing
Mandated?Voluntary: Firm initiated
Recall NumberD-1330-2022
Event ID90634
BrandPREDNISONE
Generic NamePREDNISONE
ManufacturerPREDNISONE
Original Package?1
Active SubstancePREDNISONE
Drug RouteORAL
DistributionUS Nationwide
Quantity1032 bottles
Recall ReasonPresence of foreign tablet: 2.5 mg tablet in a 20 mg bottle of Prednisone Tablets
Drug ClassificationClass II
Drug Code Info20220817
Product NDC64380-784 64380-785 64380-949
Product NUIN0000175576 N0000175450
Drug UPC0364380785088 0364380784067 0364380785064
Pharma Class (EPC)Corticosteroid [EPC]
Recall Initiation Date20220719
Report Date20220817
Classification Date20220809
Address2 Tower Center Blvd Ste 1102
East Brunswick, NJ 08816-1100
United States
Recalling FirmStrides Pharma Inc.
Initial Notification Letter
Unique Ingredient IdentifierVB0R961HZT
Drug Application NumberANDA208412
Structured Product Labeling (SPL ID)b0517ba5-d086-4c92-ae91-cd9c4c2f9faf
Structured Product Labeling (SPL Set ID)2ef05381-faad-4e0f-b58d-9f2236a04a2c
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