Sandoz Recalls Neomycin and Polymyxin B Ophthalmic Suspension for Labeling Error
Sandoz Inc. is recalling 346,929 bottles of Neomycin and Polymyxin B Sulfates and Dexamethasone Ophthalmic Suspension due to incorrect or missing package inserts.
What this means for you
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The recall is classified as FDA Class III, which indicates the product is not likely to cause adverse health consequences. The hazard is limited to a documentation issue (incorrect or missing package insert) with no reported injuries or illnesses.
Plain-English summary
Sandoz Inc. is recalling 346,929 bottles of Neomycin and Polymyxin B Sulfates and Dexamethasone Ophthalmic Suspension, a prescription-only sterile ophthalmic suspension. The product is manufactured by Alcon Laboratories, Inc. for Sandoz Inc. and is identified by NDC 61314-630-06. The recall is limited to specific lots with expiration dates ranging from October 31, 2019, to May 31, 2021.
The recall was initiated because of a labeling issue involving an incorrect or missing package insert. The affected product was distributed nationwide in the U.S. The source text does not report any illnesses, injuries, or deaths associated with this recall.
Consumers and healthcare providers should check their inventory for the specific lot numbers and expiration dates listed in the recall notice. If the product is found, it should be returned to the pharmacy or supplier for replacement or refund. Patients should consult their healthcare provider for alternative treatment options if necessary.
The recalled product
- Product
- NEOMYCIN AND POLYMYXIN B SULFATES AND DEXAMETHASONE (NEOMYCIN SULFATE, POLYMYXIN B SULFATE AND DEXAMETHASONE)
- Brand
- NEOMYCIN AND POLYMYXIN B SULFATES AND DEXAMETHASONE
- Manufacturer
- Sandoz Inc
- Category
- Drug — Ophthalmic
- Hazard
- Affected units
- 346,929
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- Lot #s: 287880F
- 287881F
- Exp. 10/31/2019
- 290555F
- Exp. 11/30/2019
- 293389F
- Exp. 2/29/2020
- 290556F
- 290557F
- 293386F
- 293387F
- Exp. 3/31/2020
- 293388F
- 293390F
- Exp. 5/31/2020
- 293391F
- Exp. 6/30/2020
- 293392F
- Exp. 7/31/2020
- 295342F
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 3 recalled by Sandoz Inc under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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