Recalls / Class II
Class IID-0118-2018
Product
NitroGlycerin (1 mg/5 mL) 1 mg in 5% Dextrose Inj, USP QS 5 mL (200 mcg per mL), 5 mL Sterile single dose syringe, packaged in 8 x 5 (FORTY) syringes per box, Rx only, Advanced Pharma, 9265 Kirby Dr., Houston, TX 77054, NDC 15082-863-67.
- Affected lot / code info
- Lot: 4/26/17 0730 20-86367S, BUD 6/25/17; 4/24/17 0106 241-86367S, BUD 6/23/17; 5/1/17 1500 45-86367S, BUD 6/30/17; 5/9/17 1103 241-86367S, BUD 7/8/17; 5/9/17 1104 257-86367S, BUD 7/8/17; 5/12/17 0839 15-86367S, BUD 7/11/17; 5/19/17 0109 15-86367S, BUD 7/18/17; 5/22/17 0828 387-86367S, BUD 7/21/17; 5/23/17 0721 257-86367S, BUD 7/22/17; 5/24/17 0200 241-86367S, BUD 7/23/17; 5/24/17 0203 20-86367S, BUD 7/23/17; 5/26/17 0315 15-86367S, BUD 7/25/17; 5/31/17 1217 20-86367S, BUD 7/30/17
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
- 680 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-0118-2018. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.