The Recall Desk
SevereFDA (Drugs)·D-1157-2017·Announced 2017-09-20

Bella Pharmaceuticals Recalls Phenylephrine/Tropicamide Ophthalmic Solution for Sterility Concerns

Bella Pharmaceuticals is recalling 6 bottles of Phenylephrine 2.5%/Tropicamide 1% Ophthalmic Solution due to a lack of assurance of sterility.

What this means for you

Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves a lack of assurance of sterility in an ophthalmic product, which poses a significant risk of infection or injury.

Plain-English summary

Bella Pharmaceuticals, Inc. is recalling 6 bottles of Phenylephrine 2.5%/Tropicamide 1% Ophthalmic Solution, 15mL bottles, prescription only. The recall is being conducted due to a lack of assurance of sterility.

The affected product is identified by Lot # BPPTC08717 with an expiration date of 11/7/17. The product was distributed nationwide within the USA.

Consumers who have this product should stop using it and contact their healthcare provider or the recalling firm for further instructions.

The recalled product

Product
Phenylephrine2.5%/Tropicamide 1% Ophthalmic Solution, 15mL bottle, Rx only, Bella Pharma 3101 W. Devon Ave., Chicago, IL 60659, 1 (877) BELLA.
Hazard
Affected units
6

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 #: BPPTC08717
  • Exp. 11/7/17

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 16 recalled by Bella Pharmaceuticals, 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.

See all 16 products in this recall →