The Recall Desk
ModerateFDA (Drugs)·D-0805-2016·Announced 2016-04-13

Meditech Formula 1 Injection Recalled Due to Expired Active Ingredient

Meditech Laboratories is recalling 1,320 vials of Formula 1 Injection because the active ingredient expired before the labeled Beyond Use Date.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves a stability issue with an expired active ingredient without reported injuries or illnesses, fitting the criteria for a moderate severity rating.

Plain-English summary

Meditech Laboratories, Inc. is recalling 1,320 vials of Formula 1 Injection, a prescription medication containing papaverine, phentolamine, atropine, and PGE. The recall is due to a stability issue where the product was manufactured with an active ingredient that expired before the labeled Beyond Use Date.

The affected lots are 011916-1 (Expiration 04/19/16) and 020316-1 (Expiration 05/03/16). The product was distributed nationwide.

Consumers and healthcare providers should stop using the recalled product and contact Meditech Laboratories for further instructions.

The recalled product

Product
Formula 1 (Papaverine 1.8 mg, Phentolamine 0.2 mg, Atropine 0.02 mg, PGE 18 mcg/mL) Injection, 5 mL vial, Rx only, Meditech Laboratories, Inc., 3200 Polaris Ave., Suite 27, Las Vegas, NV 89102.
Manufacturer
Meditech Laboratories, Inc
Category
Drug — Injection
Hazard
Affected units
1,320

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (4)

  • Lot#: 011916-1
  • Exp 04/19/16
  • 020316-1
  • Exp 05/03/16

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 7 recalled by Meditech Laboratories, Inc under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 7 products in this recall →

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