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Alembic Pharmaceuticals, Inc. FDA Recalls

2 recalls on file across drugs, 0 of them Class I and 2 still open. This firm is not matched to a listed company.

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Class I is the FDA's most serious grade: a reasonable probability of serious harm or death.

Product
Tobramycin Opthalmic Solution USP, 0.3%, 5mL bottle, Rx only, Manufactured for: Alembic Pharmaceuticals, Bedminster, NJ Class IIIJul 27, 2023Failed Impurities/Degradation Specifications
Diclofenac Sodium Topical Solution USP, 2% w/w, 3.8 FL.OZ.(112 grams) bottles, Rx only, Manufactured for: Alembic PharmClass IIJun 22, 2023Defective Delivery System

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