PlainRecalls
FDA Drug Moderate Class II Terminated

Formula 2 (Papaverine 9 mg, Phentolamine 1 mg, Atropine 0.1 mg, PGE 10 mcg/mL), 5 mL vials, Meditech Laboratories, Inc., 3200 Polaris Ave., Suite 27, Las Vegas, NV 89102.

Reported: April 13, 2016 Initiated: March 14, 2016 #D-0808-2016

Product Description

Formula 2 (Papaverine 9 mg, Phentolamine 1 mg, Atropine 0.1 mg, PGE 10 mcg/mL), 5 mL vials, Meditech Laboratories, Inc., 3200 Polaris Ave., Suite 27, Las Vegas, NV 89102.

Reason for Recall

Stability Does Not Support Expiry: manufactured with an active ingredient that expired before the labeled Beyond Use Date.

Details

Units Affected
1320 vials - all formulas
Distribution
Nationwide
Location
Las Vegas, NV

Frequently Asked Questions

What product was recalled?
Formula 2 (Papaverine 9 mg, Phentolamine 1 mg, Atropine 0.1 mg, PGE 10 mcg/mL), 5 mL vials, Meditech Laboratories, Inc., 3200 Polaris Ave., Suite 27, Las Vegas, NV 89102.. Recalled by Meditech Laboratories, Inc. Units affected: 1320 vials - all formulas.
Why was this product recalled?
Stability Does Not Support Expiry: manufactured with an active ingredient that expired before the labeled Beyond Use Date.
Which agency issued this recall?
This recall was issued by the FDA Drug on April 13, 2016. Severity: Moderate. Recall number: D-0808-2016.