Drug Enforcement D-0654-2025

Presence of a Foreign Substance: A specific lot of auxiliary polyester coil, used in product packaging by manufacturer (Amneal Pharmaceuticals LLC) was detected with presence of a micro-organism. No micro-organism was detected on any tablets.

Status

Ongoing

Classification

Class II

Report Date

September 24, 2025

Termination Date

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Product Information

Product description
Sulfamethoxazole and Trimethoprim Tablets, USP 800mg / 160mg Double Strength packaged in a) 6-count bottles (NDC 51655-307-87), b) 10-count bottles (NDC 51655-307-53), c) 14-count bottles (NDC 51655-307-84), d) 20-count bottles (NDC 51655-307-20) Rx Only, Repackaged from Amneal Pharmaceuticals LLC. Repackaged by: Northwind Pharmaceuticals, Indianapolis, IN 46203.
Product quantity
a) 96 bottles, b) 627 bottles, c) 428 bottles, d) 1144 bottles
Reason for recall
Presence of a Foreign Substance: A specific lot of auxiliary polyester coil, used in product packaging by manufacturer (Amneal Pharmaceuticals LLC) was detected with presence of a micro-organism. No micro-organism was detected on any tablets.
Recall initiation reason
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Initial firm notification
Letter
Distribution pattern
Nationwide within the United States

Location & Firm

Recalling firm
Northwind Pharmaceuticals LLC
Address
4838 Fletcher Ave Ste 1000, N/A

United States
Voluntary / Mandated
Voluntary: Firm initiated
Status date
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Codes & Dates

Recall number
D-0654-2025
Event ID
97544
Recall initiation date
August 20, 2025
Center classification date
September 17, 2025
Code info
Lot #: a) F118062503, Exp Date 05/31/2027, F118062507, Exp Date. 07/31/2027. b) F118062504, F118062505, Exp. Date 05/31/2027; F118062509, Exp. Date. 08/31/2027; F118062512, Exp. Date 04/30/2027. c) F118062506, Exp. Date 06/30/2027. d) F118062423, Exp. Date 01/31/2027; F118062501, Exp. Date 06/30/2027; F118062502, Exp. Date 04/30/2027; F118062508, Exp. Date 08/31/2027.
More code info
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