Recalling firm
ALEMBIC PHARMACEUTICALS, INC.
Product type
Drug
Status
Ongoing
Report date
2023-08-02
Distribution
Nationwide within the United States
Firm state
NJ
Product quantity
2844 units
Initiated by
Voluntary: Firm initiated
Reason for recall
Defective Delivery System
Product description
Diclofenac Sodium Topical Solution USP, 2% w/w, 3.8 FL.OZ.(112 grams) bottles, Rx only, Manufactured for: Alembic Pharmaceuticals, Inc. Bedminster, NJ 07921, USA Manufactured by: Alembic Pharmaceuticals Limited (Derma Division) Karakhadi, Vadodara 391450, India. NDC 62332-487-12
Code / lot info
Lot #: 220151, 220152, 220153, Exp. Date 11/2024
Data: U.S. FDA openFDA enforcement API. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification.