Drug Enforcement D-0530-2023

CGMP Deviations: Discoloration

Status

Ongoing

Classification

Class II

Report Date

April 19, 2023

Termination Date

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Product Information

Product description
Pantoprazole Sodium Delayed Release Tablets USP 40mg, 1000-count bottles, Rx only, Manufactured for: Camber Pharmaceuticals Inc., Piscataway, NJ, 08854, By: Hetero Labs Limited, Unit V, Polepally, Jadcherla, Mahabubnagar- 509 301, India NDC 31722-713-10
Product quantity
2,352 bottles
Reason for recall
CGMP Deviations: Discoloration
Recall initiation reason
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Initial firm notification
Letter
Distribution pattern
Nationwide within the United States

Location & Firm

Recalling firm
Hetero USA Inc
Address
1035 Centennial Ave, N/A

United States
Voluntary / Mandated
N/A
Status date
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Codes & Dates

Recall number
D-0530-2023
Event ID
91855
Recall initiation date
March 14, 2023
Center classification date
April 11, 2023
Code info
Lot #: PAN22542, Exp. Date: 9/2024
More code info
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