Recalls / Class II
Class IID-0116-2018
Product
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.
- Affected lot / code info
- Lot: 3/3/17 1830 81861S, BUD 07/01/17; 3/27/17 0658 81861S, BUD 7/25/17
Why it was recalled
Stability Data Does Not Support Expiry: lots do not have stability that supports the use of the container system.
Recalling firm
- Firm
- Advanced Pharma Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 9265 Kirby Dr, Houston, Texas 77054-2520
Distribution
- Quantity
- 4800 syringes
- Distribution pattern
- Nationwide in the USA to hospitals and medical facilities.
Timeline
- Recall initiated
- 2017-06-09
- FDA classified
- 2017-12-20
- Posted by FDA
- 2017-12-27
- Terminated
- 2019-04-03
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0116-2018. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.