The Recall Desk
SevereFDA (Drugs)·D-1009-2015·Announced 2015-05-20

Health Innovations Pharmacy Recalls Serum 50% BSS 50% Opth Drops

Health Innovations Pharmacy is recalling Serum 50% BSS 50% Opth Drops due to lack of assurance of sterility and stability data. The recall covers all lots distributed in North Carolina.

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 agency classification is FDA Class II. Per the rubric, FDA Class II recalls are assigned a severity score of 4 (Severe), particularly when involving sterility risks in pharmaceutical products.

Plain-English summary

Health Innovations Pharmacy, Inc. is recalling Serum 50% BSS 50% Opth Drops. The recall is being conducted because of recent inspection observations associated with certain quality control procedures. These observations present a risk to sterility and quality assurance, as the lack of assurance of sterility and stability data does not support the product's expiry.

The recall includes all lots of the product. The distribution pattern is limited to North Carolina. The product was manufactured by Health Innovations Pharmacy, Inc., located in Southern Pines, NC.

Consumers who have this product should stop using it and contact the recalling firm for further instructions. The FDA has classified this recall as Class II, indicating that use of or exposure to the product may cause temporary or medically reversible adverse health consequences.

The recalled product

Product
Serum 50% BSS 50% Opth Drops, Health Innov Pharmacy, 295 Pinehurst Ave, Southern Pines, NC 28387, (910) 246-5155

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 in 1 state:

Part of a larger recall action

This product is one of 65 recalled by Health Innovations Pharmacy, 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 65 products in this recall →