Meditech Formula 4 Injection Recalled for Sterility Assurance Issues
Meditech Laboratories is recalling Formula 4 Injection vials due to incomplete data regarding production sterility.
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 classified this as an FDA Class II recall. Per the rubric, FDA Class II recalls involving significant risks such as sterility assurance failures in injectable drugs are categorized as Severe.
Plain-English summary
Meditech Laboratories, Inc. is recalling 1,320 vials of Formula 4 (Papaverine 18 mg, Phentolamine 2 mg, Atropine 0.2 mg/mL) Injection, 5 mL vials. The recall is due to a lack of assurance of sterility, specifically because of incomplete or missing data regarding the production process.
The affected product is prescription-only and was distributed nationwide. The specific lot number is 022316-4, with an expiration date of 04/08/16.
Consumers and healthcare providers should stop using the affected vials and contact Meditech Laboratories or their healthcare provider for further instructions.
The recalled product
- Product
- Formula 4 (Papaverine 18 mg, Phentolamine 2 mg, Atropine 0.2 mg/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 — Injectable
- 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#: 022316-4
- Exp 04/08/16
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 →Related recalls
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