The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-0803-2016·Announced 2016-04-13

Meditech Formula 4 Injection Recalled for Sterility Assurance Issues

Meditech Laboratories is recalling Formula 4 Injection vials due to incomplete data regarding production sterility.

The agency’s classification

FDA (Drugs): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The agency classified this as an FDA Class II recall. Per the rubric, FDA Class II recalls involving significant risks such as sterility assurance failures in injectable drugs are categorized as Severe.

Plain-English summary

Meditech Laboratories, Inc. is recalling 1,320 vials of Formula 4 (Papaverine 18 mg, Phentolamine 2 mg, Atropine 0.2 mg/mL) Injection, 5 mL vials. The recall is due to a lack of assurance of sterility, specifically because of incomplete or missing data regarding the production process.

The affected product is prescription-only and was distributed nationwide. The specific lot number is 022316-4, with an expiration date of 04/08/16.

Consumers and healthcare providers should stop using the affected vials and contact Meditech Laboratories or their healthcare provider for further instructions.

The recalled product

Product
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. .
Manufacturer
Meditech Laboratories, Inc
Category
Drug — Injectable
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 (2)

  • Lot#: 022316-4
  • Exp 04/08/16

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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