Recalls / Class II
Class IID-1567-2014
Product
Glycopyrrolate 0.2 mg/ml, 5 mL pre-filled syringe, Rx Only. Pharmakon Pharmaceuticals, Inc., 14450 Getz Rd., Noblesville, IN 46060, NDC#: 45183-0965-70.
- Affected lot / code info
- Lot #: E131210.212 Exp: 07/14/2014
Why it was recalled
Incorrect/ Undeclared Excipient: Contains undeclared benzyl alcohol.
Recalling firm
- Firm
- Pharmakon Pharmaceuticals
- Notification channel
- Telephone
- Type
- Voluntary: Firm initiated
- Address
- 14450 Getz Rd, N/A, Noblesville, Indiana 46060-3303
Distribution
- Quantity
- 200 Syringes
- Distribution pattern
- United States: TX, IL, MD, IN
Timeline
- Recall initiated
- 2014-04-21
- FDA classified
- 2014-08-26
- Posted by FDA
- 2014-09-03
- Terminated
- 2014-12-03
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1567-2014. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.