The Recall Desk
HighFDA (Drugs)·D-0033-2023·Announced 2022-11-09

Glycerin Ophthalmic Drops Recalled Due to Sterility Manufacturing Concerns

Pharmacy Plus, Inc. dba Vital Care Compounder is recalling Glycerin Ophthalmic Drops 98.5% Solution because manufacturing methods cannot guarantee the sterility of the product. Products affected are distributed in Alabama, Louisiana, Mississippi, and Tennessee.

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: This is an FDA Class II recall for a prescription ophthalmic medication with confirmed manufacturing control deficiencies that cannot assure sterility. No illnesses or injuries have been reported. Per the rubric, this is a risk-of-harm product where injury has not yet been reported, warranting a High severity score.

Plain-English summary

Pharmacy Plus, Inc. dba Vital Care Compounder has recalled Glycerin Ophthalmic Drops 98.5% Solution, a prescription eye medication. The recall was initiated after an FDA inspection determined that the products were manufactured in a manner that cannot assure sterility.

The recalled product is a 10 mL droptainer with lot number 65416 and a Beyond-Use Date of 10/13/2022. It was distributed in Alabama, Louisiana, Mississippi, and Tennessee.

If you have this product, contact your pharmacist or healthcare provider for guidance. Do not use the product.

The recalled product

Product
GLYCERIN OPHTHALMIC DROPS 98.5% Solution, 10 mL droptainer, Rx only, Vital Care Compounder, 115 S. 40th Ave., Hattiesburg, MS 39402
Manufacturer
Pharmacy Plus, Inc. dba Vital Care Compounder
Hazard
  • lack-of-sterility
  • contamination-risk

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 (2)

  • Lot: 65416
  • BUD: 10/13/2022

Distribution

Distributed in 4 states:

  • AL
  • LA
  • MS
  • TN