The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-0808-2016·Announced 2016-04-13

Meditech Formula 2 Vials Recalled Due to Expired Active Ingredient

Meditech Laboratories is recalling Formula 2 vials because an active ingredient expired before the labeled Beyond Use Date.

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 FDA classified this recall as Class II. Per the rubric, FDA Class II recalls are assigned a severity score of 4 (Severe), particularly when the defect involves the stability of active ingredients which may lead to adverse health consequences.

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). The product is identified by Lot # 12216-2 and has an expiration date of 04/22/16. The recall was initiated because the product was manufactured with an active ingredient that expired before the labeled Beyond Use Date, meaning the stability of the medication does not support the stated expiry.

The affected vials were distributed nationwide. The FDA has classified this recall as Class II, indicating that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

Consumers and healthcare providers should stop using the affected vials and contact Meditech Laboratories or their healthcare provider for instructions on how to return or dispose of the product.

The recalled product

Product
Formula 2 (Papaverine 9 mg, Phentolamine 1 mg, Atropine 0.1 mg, PGE 10 mcg/mL), 5 mL vials, Meditech Laboratories, Inc., 3200 Polaris Ave., Suite 27, Las Vegas, NV 89102.
Manufacturer
Meditech Laboratories, Inc
Category
Drug — Injectable Medication
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 #: 12216-2
  • Exp 04/22/16

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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