← FDA ENFORCEMENT
D-1086-2023Class III

ALEMBIC PHARMACEUTICALS, INC.

Recalling firm
ALEMBIC PHARMACEUTICALS, INC.
Product type
Drug
Status
Ongoing
Report date
2023-08-23
Distribution
Nationwide in the USA
Firm state
NJ
Product quantity
82,400 bottles
Initiated by
Voluntary: Firm initiated
SPEQ quality domain
Validation & Qualification
Reason for recall

Failed Impurities/Degradation Specifications

Product description

Tobramycin Opthalmic Solution USP, 0.3%, 5mL bottle, Rx only, Manufactured for: Alembic Pharmaceuticals, Bedminster, NJ 07921, USA, NDC 62332-518-05

Code / lot info

Lot #: AMR103, Exp: 10/2023; Lot#: AMR201, Exp: 06/2024

Other recalls SPEQ maps to Validation & Qualification
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See all Validation & Qualification recalls →

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.