Good Neighbor Pharmacy PEG-Phen Lubricant Eye Drops (Polyethylene Glycol 400 0.4% / Propylene Gly...

FDA Drug Recall #D-0835-2016 — Class II — April 7, 2016

Recall Summary

Recall Number D-0835-2016
Classification Class II — Moderate risk
Date Initiated April 7, 2016
Status Terminated
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm Akorn, Inc.
Location Lake Forest, IL
Product Type Drugs
Quantity 10,060 bottles (Good Neighbor Pharmacy: 6,731 bottles/Premier Value Brand: 3,323 bottles)

Product Description

Good Neighbor Pharmacy PEG-Phen Lubricant Eye Drops (Polyethylene Glycol 400 0.4% / Propylene Glycol 0.3%), 15 ml bottle, Distributed by AmerisourceBergen, 1300 Morris Drive, Chesterbrook, PA 19087, NDC 46122-199-05, ALSO labeled as Premier Value Brand PEG-Phen Lubricant Eye Drops (Polyethylene Glycol 400 0.4% / Propylene Glycol 0.3%), 15 ml bottle, Distributed by Chain Drug Consortium, 3301 NW Boca Raton Blvd, Suite 101, Boca Raton, FL 33431, NDC 68016-0404-00.

Reason for Recall

Presence of Particulate Matter

Distribution Pattern

Nationwide

Lot / Code Information

Good Neighbor Pharmacy Batch Number 4H76A; Exp 07/16 Premier Value Batch Number 4H76B; Exp 07/16

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D-0790-2023 Class II Calcitriol Injection 1 mcg/mL, 1 mL ampules Rx ... Apr 26, 2023
D-0820-2023 Class II Levofloxacin Ophthalmic Solution, 0.5%, 5 mL bo... Apr 26, 2023
D-0849-2023 Class II Timolol Maleate Ophthalmic Solution, USP 0.5%, ... Apr 26, 2023

Frequently Asked Questions

Stop taking the medication and contact your pharmacist or doctor immediately. For Class I recalls, this is urgent. For Class II or III recalls, consult your doctor before stopping — abruptly discontinuing certain medications (blood pressure drugs, antidepressants, diabetes medications) can be more harmful than continuing while arranging a replacement. Check whether the recall applies to your specific lot number and expiration date. Return the product to your pharmacy and report any adverse effects to FDA MedWatch at 1-800-FDA-1088.

Not necessarily. Many drug recalls are initiated because of quality system failures or test results that suggest a product might not meet specifications — even if no patients have reported harm. The FDA uses a precautionary approach: if there is reason to believe quality standards were not met, a recall is required regardless of whether adverse effects have been reported. Class I recalls typically involve a reasonable probability of harm; Class II recalls may cause temporary health issues; Class III recalls are for products unlikely to cause adverse health consequences but that still violate regulations.

Pharmacies typically receive recall notices directly from drug wholesalers and manufacturers within days of the recall being announced. Your pharmacist can look up whether any product in your prescription history matches a recalled lot number. For current recalls, the FDA publishes updates at FDA.gov/safety/recalls-market-withdrawals-safety-alerts and sends MedWatch email alerts for significant drug safety issues. You can sign up for MedWatch alerts at FDA.gov. Most major pharmacy chains also have their own recall notification systems that automatically alert pharmacists when a recalled product is in their inventory.

What Should You Do?

Stop using this medication if affected by this recall. Contact your pharmacist or prescribing doctor immediately for guidance. Do not flush medications — use a drug take-back program.