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Formula 4 (Papaverine 18 mg, Phentolamine 2 mg, Atropine 0.2 mg/mL) Injection, 5 mL vials, Rx onl...

FDA Recall #D-0803-2016 — Class II — March 14, 2016

Recall #D-0803-2016 Date: March 14, 2016 Classification: Class II Status: Terminated

Product Description

Formula 4 (Papaverine 18 mg, Phentolamine 2 mg, Atropine 0.2 mg/mL) Injection, 5 mL vials, Rx only, Meditech Laboratories, Inc., 3200 Polaris Ave., Suite 27, Las Vegas, NV 89102. .

Reason for Recall

Lack of Assurance of Sterility: incomplete or missing data regarding production.

Recalling Firm

Meditech Laboratories, Inc — Las Vegas, NV

Classification

Class II — May cause temporary or medically reversible adverse health consequences.

Product Type

Drugs

Product Quantity

1320 vials - all formulas

Distribution

Nationwide

Code Information

Lot#: 022316-4, Exp 04/08/16

Status

Terminated

Voluntary / Mandated

Voluntary: Firm initiated

What Should You Do?

Stop using this medication immediately and contact your pharmacist or doctor. Do not flush medications down the drain. Return the product to the place of purchase for a refund or replacement.

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