FDA-Drug2016-04-13Class II
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.
Meditech Laboratories, Inc
Hazard
Superpotent Drug: one ingredient was found to be above assay specification.
Sold states
Nationwide
Affected count
1320 vials - all formulas
Manufactured in
3200 Polaris Ave Ste 27, N/A, Las Vegas, NV, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0802-2016Don't want to check this manually?
We email you a Sunday digest of new federal recalls relevant to parents — free, no credit card. Or upgrade to as-it-happens alerts for the brands you actually own.
Get the Sunday Brief