FDA Recall D-0391-2025

Preferred Pharmaceuticals, Inc. · Anaheim, CA

Class II Ongoing 391 days on record

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

Product

Clindamycin Hydrochloride Capsules, USP, 300mg, 30-count bottles, Manufactured by: Glenmark Pharmaceuticals Limited, NDC 68788-8685-03.

Lot / code: Lot #: L0224T, K1824M, K0124N, J1624V, J0824O, I2424E, I1024O, A0925F, L2324L, Exp: 7/31/2026.

Quantity: 1190 Bottles

Reason for recall

cGMP Deviations

Recall record

Recall number: D-0391-2025
Classification: Class II
Status: Ongoing
Voluntary or mandated: Voluntary: Firm initiated
Firm notification: Letter
Distribution: Nationwide in the US
Recall initiated: 2025-04-18
Classified by FDA Center: 2025-04-28
FDA published: 2025-05-07
Recalling firm: Preferred Pharmaceuticals, Inc.
Firm location: Anaheim, CA

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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