Recalls / Class II
Class IID-0802-2016
Product
Formula 2 (Papaverine 9 mg, Phentolamine 1 mg, Atropine 0.1 mg, PGE 10 mcg/mL) Injection, 5 mL vials, Rx only, Meditech Laboratories, Inc., 3200 Polaris Ave., Suite 27, Las Vegas, NV 89102.
- Affected lot / code info
- Lot #: 110115-2, Exp 01/01/16
Why it was recalled
Superpotent Drug: one ingredient was found to be above assay specification.
Recalling firm
- Firm
- Meditech Laboratories, Inc
- Notification channel
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Type
- Voluntary: Firm initiated
- Address
- 3200 Polaris Ave Ste 27, N/A, Las Vegas, Nevada 89102-8379
Distribution
- Quantity
- 1320 vials - all formulas
- Distribution pattern
- Nationwide
Timeline
- Recall initiated
- 2016-03-14
- FDA classified
- 2016-04-01
- Posted by FDA
- 2016-04-13
- Terminated
- 2016-06-07
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0802-2016. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.