FDAClass IIApril 13, 2016

Formula 3 recall

Formula 3 (Papaverine 20 mg, Phentolamine 3 mg, Atropine 0.2 mg, PGE 20 mcg/mL) Injection, 5 mL vials, Rx only, Meditech Laboratories, Inc., 3200…

Why was Formula 3 recalled?

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

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Lot#: 011716-3, Exp 04/17/16; 012416-3, Exp 04/24/16.

Product
Formula 3 (Papaverine 20 mg, Phentolamine 3 mg, Atropine 0.2 mg, PGE 20 mcg/mL) Injection, 5 mL vials, Rx only, Meditech Laboratories, Inc., 3200…
Recalling firm
Meditech Laboratories, Inc
Quantity
1320 vials - all formulas
Distribution
Nationwide
Recall date
April 13, 2016
Classification
Class II
Status
Terminated
Agency
FDA (drug)
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