The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-0802-2016·Announced 2016-04-13

Meditech Formula 2 Injection Recalled for Superpotent Drug Ingredient

Meditech Laboratories is recalling Formula 2 Injection vials because one ingredient exceeded assay specifications, making the drug superpotent.

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 injury or property damage reports, or structural defects, are rated Severe. While no specific injuries are reported in the text, the 'superpotent' nature of the drug and the agency's Class II classification align with the Severe criteria for significant risk.

Plain-English summary

Meditech Laboratories, Inc. is recalling 1,320 vials of Formula 2 (Papaverine 9 mg, Phentolamine 1 mg, Atropine 0.1 mg, PGE 10 mcg/mL) Injection. The recall affects 5 mL vials, prescription only, with Lot # 110115-2 and an expiration date of 01/01/16. The product was distributed nationwide.

The recall was initiated because the product is classified as a superpotent drug, with one ingredient found to be above assay specification. This deviation from the specified potency levels poses a risk to patients using the medication.

Patients and healthcare providers should stop using the affected vials and contact their healthcare provider or pharmacist for guidance. The recalling firm is Meditech Laboratories, Inc., located in Las Vegas, Nevada.

The recalled product

Product
Formula 2 (Papaverine 9 mg, Phentolamine 1 mg, Atropine 0.1 mg, PGE 10 mcg/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 — 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 (2)

  • Lot #: 110115-2
  • Exp 01/01/16

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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