Akorn Recalls Moisturizing Lubricant Eye Drops Due to Stability Failure
Akorn Inc is recalling specific lots of Moisturizing Lubricant Eye Drops because they failed stability specifications for Sodium Perborate.
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 voluntary precautionary recall.
Plain-English summary
Akorn Inc is voluntarily recalling 78,120 dropper bottles of Moisturizing Lubricant Eye Drops, 0.25% Sodium Carboxymethylcellulose, 0.5 Fl OZ (15mL). The product is distributed by Walgreen Co and is identified by NDC 00363-9651-01.
The recall was initiated because the product failed stability specifications, specifically showing out-of-specification results for Sodium Perborate. The affected lots are 8D31A (Exp: 03/20), 7H98A (Exp: 07/19), and 7L80A (Exp: 10/19).
The product was distributed nationwide in the USA. Consumers should check their eye drops for the specific lot numbers and expiration dates listed above. If they have the affected product, they should stop using it and contact their pharmacist or the recalling firm for instructions on return or disposal.
The recalled product
- Product
- Moisturizing Lubricant Eye Drops, 0.25% Sodium Carboxymethylcellulose, 0.5 Fl OZ (15mL) Distributed by: Walgreen Co, 200 Wilmont Rd Deerfield IL 60015 NDC 00363-9651-01.
- Manufacturer
- Akorn Inc
- Category
- Drug — Ophthalmic
- Affected units
- 78,120
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 (6)
- Lot # 8D31A
- Exp: 03/20
- 7H98A
- Exp: 07/19
- 7L80A
- Exp: 10/19.
Distribution
Distributed nationwide across the United States.
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