Methylprednisolone Ophthalmic Drops Recalled for Lack of Sterility Assurance
Anderson Compounding Pharmacy is recalling Methylprednisolone 1% PF Ophthalmic drops due to a lack of sterility assurance. The recall covers all lots distributed nationwide.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II. The hazard involves a lack of sterility assurance in an ophthalmic product, which poses a risk of harm (infection) even though no specific illnesses are reported in the source text. This aligns with the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Anderson Compounding Pharmacy, Inc. is recalling Methylprednisolone 1% PF Ophthalmic, 3 mL Droppers. The recall was initiated because the product lacks sterility assurance. The affected product consists of 5 drop containers.
The recall covers all lots of the product. Distribution was nationwide. The source text does not specify specific dates or additional geographic details beyond the nationwide distribution pattern.
Consumers should stop using the recalled product. The source text does not provide specific instructions for disposal or return, nor does it report any illnesses or injuries associated with the use of this product.
The recalled product
- Product
- Methylprednisolone 1% PF Ophthalmic, 3 mL Droppers, Anderson Compounding Pharmacy 310 Bluff City Hwy, Bristol, TN.
- Category
- Drug — Ophthalmic
- Hazard
- Affected units
- 5
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 (1)
- All Lots
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 68 recalled by Anderson Compounding Pharmacy, Inc. DBA Anderson Compounding Pharmacy 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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