Why it was recalled
Non-Sterility: FDA found insanitary conditions and positive bacterial test results from environmental sampling at the manufacturing facility.
Product description
Polyvinyl Alcohol 1.4% Lubricating Eye Drops, packaged in 0.5 FL OZ (15mL) bottles, Dist. by: RUGBY LABORATORIES, Livonia, MI 48152, NDC 0536-1325-94.
Lot numbers, UPCs & expiration codes
All lots
Where it was sold
Nationwide within the United States
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0107-2024
- Classification
- Class I
- Status
- Terminated
- Recall initiated
- Oct 31, 2023
- FDA report date
- Nov 29, 2023
- Quantity
- 1,271,810 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories
Original FDA data
Every field from FDA enforcement report D-0107-2024, exactly as published.
Show all FDA fields
- City
- La Vergne
- State
- TN
- Status
- Terminated
- Country
- United States
- Event ID
- 93339
- Address
- 341 Mason Rd
- Code information
- All lots
- Postal code
- 37086-3606
- Report date
- Nov 29, 2023
- Product type
- Drugs
- Recall number
- D-0107-2024
- Classification
- Class I
- Recalling firm
- The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories
- Product quantity
- 1,271,810 bottles
- Termination date
- Apr 15, 2025
- Reason for recall
- Non-Sterility: FDA found insanitary conditions and positive bacterial test results from environmental sampling at the manufacturing facility.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Polyvinyl Alcohol 1.4% Lubricating Eye Drops, packaged in 0.5 FL OZ (15mL) bottles, Dist. by: RUGBY LABORATORIES, Livonia, MI 48152, NDC 0536-1325-94.
- Distribution pattern
- Nationwide within the United States
- Recall initiation date
- Oct 31, 2023
- Initial firm notification
- Letter
- Center classification date
- Nov 17, 2023