Drug Enforcement D-0310-2025

Presence of Foreign Substance: Product complaint received for the presence of foreign material embedded resembling a metal shaving in one tablet.

Status

Ongoing

Classification

Class II

Report Date

April 16, 2025

Termination Date

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Product Information

Product description
Venlafaxine Tablets, USP, 75 mg, 100 Tablets, Rx only, Mfg. by: Zydus Lifesciences Ltd, Ahmedabad, India, Dist. by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534, NDC 68382-021-01.
Product quantity
13,128 100-Count Bottles
Reason for recall
Presence of Foreign Substance: Product complaint received for the presence of foreign material embedded resembling a metal shaving in one tablet.
Recall initiation reason
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Initial firm notification
E-Mail
Distribution pattern
US Nationwide.

Location & Firm

Recalling firm
Zydus Pharmaceuticals (USA) Inc
Address
73 Route 31 N, N/A

United States
Voluntary / Mandated
Voluntary: Firm initiated
Status date
—

Codes & Dates

Recall number
D-0310-2025
Event ID
96553
Recall initiation date
March 21, 2025
Center classification date
April 4, 2025
Code info
Lot #: M314265, Exp.: 31 October 2025.
More code info
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