Why it was recalled
Subpotent Drug: found to be below the specification for labeled assay.
Product description
NitroGlycerin 1 mg/10 mL in 5% Dextrose Inj, USP QS 10mL (100 mcg per mL), 10 mL Sterile single dose syringe, packaged in 5 x 5 (TWENTY FIVE) syringes per box, Rx only, Advanced Pharma, 9265 Kirby Dr., Houston, TX 77054, NDC 15082-818-61.
Lot numbers, UPCs & expiration codes
Lot: 4/17/17 0857 81861S, BUD 08/15/2017
Where it was sold
Nationwide in the USA to hospitals and medical facilities.
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-0113-2018
- Classification
- Class I
- Status
- Terminated
- Recall initiated
- Jun 9, 2017
- FDA report date
- Dec 27, 2017
- Quantity
- 550 syringes
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Advanced Pharma Inc.
Original FDA data
Every field from FDA enforcement report D-0113-2018, exactly as published.
Show all FDA fields
- City
- Houston
- State
- TX
- Status
- Terminated
- Country
- United States
- Event ID
- 77503
- Address
- 9265 Kirby Dr
- Code information
- Lot: 4/17/17 0857 81861S, BUD 08/15/2017
- Postal code
- 77054-2520
- Report date
- Dec 27, 2017
- Product type
- Drugs
- Recall number
- D-0113-2018
- Classification
- Class I
- Recalling firm
- Advanced Pharma Inc.
- Product quantity
- 550 syringes
- Termination date
- Apr 3, 2019
- Reason for recall
- Subpotent Drug: found to be below the specification for labeled assay.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- NitroGlycerin 1 mg/10 mL in 5% Dextrose Inj, USP QS 10mL (100 mcg per mL), 10 mL Sterile single dose syringe, packaged in 5 x 5 (TWENTY FIVE) syringes per box, Rx only, Advanced Pharma, 9265 Kirby Dr., Houston, TX 77054, NDC 15082-818-61.
- Distribution pattern
- Nationwide in the USA to hospitals and medical facilities.
- Recall initiation date
- Jun 9, 2017
- Initial firm notification
- Letter
- Center classification date
- Dec 20, 2017