The Recall Registry
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Home Prescription medicine ALEMBIC PHARMACEUTICALS, INC. — Tobramycin…

Food & drug recall · FDAJuly 27, 2023Labelling issue

ALEMBIC PHARMACEUTICALS, INC. — Tobramycin Opthalmic Solution USP, 0.3%, 5mL bottle, Rx only

Do not stop taking this without speaking to your pharmacist or doctor.

What’s wrong

Failed Impurities/Degradation Specifications

The Recall Registry rates this labelling issueFDA Class III: unlikely to cause harm.

What to do

Check the lot numbers below against what you have. Do not stop taking a prescription medicine because of a recall without speaking to your pharmacist or doctor first — for many medicines stopping is more harmful than continuing, and they can tell you whether yours is affected and what to do about it.

Who to contact: Recalling firm: ALEMBIC PHARMACEUTICALS, INC.

The product

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

Details

Units affected
82,400 bottles
Recall date
July 27, 2023
Brand
ALEMBIC PHARMACEUTICALS, INC.
Model, lot or SKU numbers
Lot #: AMR103, Exp: 10/2023Lot#: AMR201, Exp: 06/2024
Where it was distributed

Nationwide in the USA

The official notice

This recall was issued by the U.S. Food and Drug Administration. The Recall Registry summarises it — always confirm the details at the source.

Their exact wording: ALEMBIC PHARMACEUTICALS, INC. — Tobramycin Opthalmic Solution USP, 0.3%, 5mL bottle, Rx only, Manufactured for: Alembic Pharmaceuticals, Bedminster, NJ 07921, USA, NDC 62332-518-05

Read it on FDA

Worried about the other things in your house? You can write down what you have and be told if one is recalled — or, if you sell second-hand, check your whole stock at once.

Filed under: Prescription medicine

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