Meditech Formula 9 Injection Recalled for Sterility Assurance Issues
Meditech Laboratories is recalling Formula 9 Injection vials due to incomplete production data regarding sterility assurance.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The agency classification is FDA Class II. The hazard involves a lack of sterility assurance for an injectable drug, which poses a significant risk of serious injury or infection, meeting the criteria for a Severe rating.
Plain-English summary
Meditech Laboratories, Inc. is recalling 1,320 vials of Formula 9 Injection (Papaverine 0.9 mg, Phentolamine 0.1 mg, Atropine 0.01 mg, PGE 20 mcg/mL). The product is a prescription-only medication distributed nationwide. The specific lot number is 022416-9, with an expiration date of 04/09/16.
The recall was initiated due to a lack of assurance of sterility. The source text indicates that there is incomplete or missing data regarding the production process, which prevents verification that the product is sterile.
Consumers and healthcare providers should stop using the affected vials and contact Meditech Laboratories or their healthcare provider for further instructions on disposal or replacement.
The recalled product
- Product
- Formula 9 (Papaverine 0.9 mg, Phentolamine 0.1 mg, Atropine 0.01 mg, PGE 20 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 — 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#: 022416-9
- Exp 04/09/16.
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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