The Recall Desk
ModerateFDA (Drugs)·D-0835-2016·Announced 2016-05-11

Akorn Recalls PEG-Phen Lubricant Eye Drops Due to Particulate Matter

Akorn, Inc. is recalling specific batches of PEG-Phen Lubricant Eye Drops because they contain particulate matter. Consumers should stop using the affected products.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II, and the source text does not report any illnesses or injuries, fitting the criteria for a moderate severity recall involving a potential hazard without confirmed harm.

Plain-English summary

Akorn, Inc. is recalling 10,060 bottles of PEG-Phen Lubricant Eye Drops (Polyethylene Glycol 400 0.4% / Propylene Glycol 0.3%), 15 ml bottles, due to the presence of particulate matter. The recalled products are distributed nationwide under two brand names: Good Neighbor Pharmacy (NDC 46122-199-05) and Premier Value Brand (NDC 68016-0404-00).

The recall affects 6,731 bottles of Good Neighbor Pharmacy PEG-Phen Lubricant Eye Drops with Batch Number 4H76A and an expiration date of 07/16. It also affects 3,323 bottles of Premier Value Brand PEG-Phen Lubricant Eye Drops with Batch Number 4H76B and an expiration date of 07/16. The products are distributed by AmerisourceBergen and Chain Drug Consortium, respectively.

Consumers should stop using the affected eye drops and check their inventory for the specific batch numbers and expiration dates listed above. The source text does not report any illnesses or injuries associated with this recall.

The recalled product

Product
Good Neighbor Pharmacy PEG-Phen Lubricant Eye Drops (Polyethylene Glycol 400 0.4% / Propylene Glycol 0.3%), 15 ml bottle, Distributed by AmerisourceBergen, 1300 Morris Drive, Chesterbrook, PA 19087, NDC 46122-199-05, ALSO labeled as Premier Value Brand PEG-Phen Lubricant Eye D
Manufacturer
Akorn, Inc.
Category
Drug — Ophthalmic
Hazard

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 (3)

  • Good Neighbor Pharmacy Batch Number 4H76A
  • Exp 07/16 Premier Value Batch Number 4H76B
  • Exp 07/16

Distribution

Distributed nationwide across the United States.

Related recalls

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Same hazard · particulate matter

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