Meditech Formula 3 Injection Recalled Due to Expired Active Ingredient
Meditech Laboratories is recalling Formula 3 Injection vials 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. The hazard involves an expired active ingredient affecting product stability, which is a quality issue without reported injuries or illnesses, fitting the Moderate severity criteria for low-risk contamination or voluntary precautionary recalls.
Plain-English summary
Meditech Laboratories, Inc. is recalling 1,320 vials of Formula 3 Injection (Papaverine 20 mg, Phentolamine 3 mg, Atropine 0.2 mg, PGE 20 mcg/mL). The product is a prescription-only medication distributed nationwide.
The recall was initiated because the product was manufactured with an active ingredient that expired before the labeled Beyond Use Date. This stability issue means the product does not support its labeled expiry dates. The affected lots are 011716-3 (Exp 04/17/16) and 012416-3 (Exp 04/24/16).
Healthcare providers and patients should stop using the affected vials and contact Meditech Laboratories or their healthcare provider for further instructions.
The recalled product
- Product
- Formula 3 (Papaverine 20 mg, Phentolamine 3 mg, Atropine 0.2 mg, PGE 20 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
- 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#: 011716-3
- Exp 04/17/16
- 012416-3
- Exp 04/24/16.
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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