Why it was recalled
Lack of Assurance of Sterility
Product description
Calcium Gluconate1% Eyewash 10 mg/mL, 125 mL bottles, Pharm D Solutions, Houston, Texas ---- NDC 69699-0906-12
Lot numbers, UPCs & expiration codes
Lots: 05072018:46 Discard by: 5/1/2019; 07122018:30 Discard by: 7/7/2019
Where it was sold
Nationwide
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-0147-2019
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Sep 10, 2018
- FDA report date
- Nov 7, 2018
- Quantity
- 29 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Pharm D Solutions, LLC
Original FDA data
Every field from FDA enforcement report D-0147-2019, exactly as published.
Show all FDA fields
- City
- Houston
- State
- TX
- Status
- Terminated
- Country
- United States
- Event ID
- 81002
- Address
- 1304 S Loop W
- Code information
- Lots: 05072018:46 Discard by: 5/1/2019; 07122018:30 Discard by: 7/7/2019
- Postal code
- 77054-4010
- Report date
- Nov 7, 2018
- Product type
- Drugs
- Recall number
- D-0147-2019
- Classification
- Class II
- Recalling firm
- Pharm D Solutions, LLC
- Product quantity
- 29 bottles
- Termination date
- Feb 5, 2021
- Reason for recall
- Lack of Assurance of Sterility
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Calcium Gluconate1% Eyewash 10 mg/mL, 125 mL bottles, Pharm D Solutions, Houston, Texas ---- NDC 69699-0906-12
- Distribution pattern
- Nationwide
- Recall initiation date
- Sep 10, 2018
- Initial firm notification
- Press Release
- Center classification date
- Nov 1, 2018