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.
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 2/5 (Moderate).
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
- 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.
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