FDA Recall D-0498-2024

MACLEODS PHARMA USA, INC · Princeton, NJ

Class II Ongoing 737 days on record

Moderate impact — Class II recall — temporary or medically reversible adverse health consequence possible; remote probability of serious adverse health consequence.

Product

Losartan Potassium and Hydrochlorothiazide Tablets, USP 50mg /12.5 mg, 1000-count bottle, Rx only, Manufactured for: Macleods Pharma USA, Inc. Princeton, NJ 08540, Manufactured by: Macleods Pharmaceuticals Ltd. Baddi, Himachal Pradesh, INDIA, NDC 33342-050-44

Lot / code: Lot #: BLK2304A, Exp. 07/31/2025

Quantity: 1,048 bottles

Reason for recall

Presence of foreign substance: plastic-like substance.

Recall record

Recall number: D-0498-2024
Classification: Class II
Status: Ongoing
Voluntary or mandated: Voluntary: Firm initiated
Firm notification: N/A
Distribution: USA Nationwide
Recall initiated: 2024-05-07
Classified by FDA Center: 2024-05-15
FDA published: 2024-05-22
Recalling firm: MACLEODS PHARMA USA, INC
Firm location: Princeton, NJ

Drug identification

Brand name(s): LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE
Generic name(s): LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE
Manufacturer(s): Macleods Pharmaceuticals Limited
NDC(s): 33342-050, 33342-051, 33342-052
Route(s): ORAL

Operational response

Class II recalls indicate possible temporary or reversible health consequences. Remove affected lots from active dispensing. Segregate inventory. Check the firm’s recall notification for guidance on patient outreach.

For the official FDA enforcement record, see FDA's Recall Search.

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