Meditech Formula 0 Injection Recalled for Sterility Assurance Issues
Meditech Laboratories is recalling Formula 0 Injection 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 recall is classified as FDA Class II, which corresponds to a Severe severity score under the rubric for significant potential health risks.
Plain-English summary
Meditech Laboratories, Inc. is recalling Formula 0 (PGE 20 mcg/mL) Injection, 5 mL vials. The recall involves 1,320 vials across all formulas, specifically Lot 020716-0 with an expiration date of 05/07/16. The product was distributed nationwide.
The recall was initiated because of a lack of assurance of sterility, resulting from incomplete or missing data regarding the production process. This is a prescription-only medication.
Consumers and healthcare providers should stop using the affected product and contact Meditech Laboratories or their healthcare provider for further instructions.
The recalled product
- Product
- Formula 0 (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
- 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#: 020716-0
- Exp 05/07/16
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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