Drug Enforcement D-0470-2025

Presence of a foreign substance: black hair found embedded in tablet.

Status

Ongoing

Classification

Class III

Report Date

June 18, 2025

Termination Date

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Product Information

Product description
Levothyroxine Sodium Tablets, USP 112 mcg (0.112mg), 1000 tablets, Rx Only, Manufactured for: Macleods Pharma USA, Inc. Princeton, NJ 08540. Manufactured by: Macleods Pharmaceuticals Ltd. Sarigam, Valsad, Gujarat, India, NDC 33342-398-44.
Product quantity
1,344- 1000 count bottles
Reason for recall
Presence of a foreign substance: black hair found embedded in tablet.
Recall initiation reason
—
Initial firm notification
Letter
Distribution pattern
Nationwide in the USA

Location & Firm

Recalling firm
Macleods Pharmaceuticals Ltd
Address
304 Atlanta Arcade, Church Road

India
Voluntary / Mandated
Voluntary: Firm initiated
Status date
—

Codes & Dates

Recall number
D-0470-2025
Event ID
96979
Recall initiation date
May 29, 2025
Center classification date
June 12, 2025
Code info
Lot #: MLF2401A, Exp 01/31/2026
More code info
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