Why it was recalled
Lack of Assurance of Sterility
Product description
Calcium Gluconate 2.5% a) 250 mL 25 mg/mL NDC 69699-0908-25; b) Nasal Spray 2.5 Inhal Soln. NDC 69699-0908-10; c) Nebulization Solution 2.5% Inhal. Soln NDC 69699-0908-10; d) Nebulization 250 mL 2.5% Inhal Soln NDC 69699-0908-25; e) Oral Spray 2.5% 2.5% Oral Soln NDC 69699-0917-60, Pharm D Solutions, Houston, Texas
Lot numbers, UPCs & expiration codes
Lots: a) 05072018:40 Discard by: 5/2/2019; b) 07262018:44 Discard by: 1/22/2019; c) 07122018:83 Discard by: 7/12/2019; d) 07262018:93 Discard by: 1/22/2019; e) 07262018:81 Discard by: 1/21/2019
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-0149-2019
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- Sep 10, 2018
- FDA report date
- Nov 7, 2018
- Quantity
- 57 bottles; 2300 milliliters
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Pharm D Solutions, LLC
Original FDA data
Every field from FDA enforcement report D-0149-2019, 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: a) 05072018:40 Discard by: 5/2/2019; b) 07262018:44 Discard by: 1/22/2019; c) 07122018:83 Discard by: 7/12/2019; d) 07262018:93 Discard by: 1/22/2019; e) 07262018:81 Discard by: 1/21/2019
- Postal code
- 77054-4010
- Report date
- Nov 7, 2018
- Product type
- Drugs
- Recall number
- D-0149-2019
- Classification
- Class III
- Recalling firm
- Pharm D Solutions, LLC
- Product quantity
- 57 bottles; 2300 milliliters
- Termination date
- Feb 5, 2021
- Reason for recall
- Lack of Assurance of Sterility
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Calcium Gluconate 2.5% a) 250 mL 25 mg/mL NDC 69699-0908-25; b) Nasal Spray 2.5 Inhal Soln. NDC 69699-0908-10; c) Nebulization Solution 2.5% Inhal. Soln NDC 69699-0908-10; d) Nebulization 250 mL 2.5% Inhal Soln NDC 69699-0908-25; e) Oral Spray 2.5% 2.5% Oral Soln NDC 69699-0917-60, Pharm D Solutions, Houston, Texas
- Distribution pattern
- Nationwide
- Recall initiation date
- Sep 10, 2018
- Initial firm notification
- Press Release
- Center classification date
- Nov 1, 2018