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Hetero Labs Limited (Unit V): Pantoprazole Sodium, Delayed-Release Tablets, USP, 40 mg, 1000-count bottle, Rx only, Manufactured for: Camber Pharmaceuticals, Inc., Piscat

DrugsSource: FDA (drug) · Date: 2026-04-29

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The text below is copied from the official FDA (drug) record. If anything differs, the official notice is correct.

Company / brand
Hetero Labs Limited (Unit V)
Product
Pantoprazole Sodium, Delayed-Release Tablets, USP, 40 mg, 1000-count bottle, Rx only, Manufactured for: Camber Pharmaceuticals, Inc., Piscataway, NJ 08854, By: Hetero, Hetero Labs Limited, Unit V, Polepally, Jadcherta, Mahabubager-509 301, India, NDC 31722-713-10
Reason / hazard
Discoloration: Firm received five (5) complaints stating that, "Tablets discolored darker than normal and have lighter-colored spots."
Classification
Class II
Status
Ongoing
Distribution / sold at
Nationwide in the USA.
Recall initiated
2026-03-26
Code info
Batch # FD253967, Exp Date: 06/26/2027
Product quantity
4,740 1,000-count bottles.
Voluntary mandated
Voluntary: Firm initiated
City
Mahabubnagar
State
N/A
Country
India
Event id
98671
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