Meditech Recalls Formula 0 Injection Due to Sterility Risks
Meditech Laboratories recalls 1320 vials of Formula 0 injection due to lack of sterility assurance. Check lot numbers and expiration dates.
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Lack of Assurance of Sterility: incomplete or missing data regarding production.
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What happened, in plain English
Meditech Laboratories, Inc. is recalling Formula 0 (PGE 20 mcg/mL) Injection in 5 mL vials because there is incomplete or missing data regarding production, leading to a lack of assurance of sterility. The recall affects 1320 vials distributed nationwide. The record does not specify a remedy for consumers. Read more at govinfonow.com/recall/43111-meditech-recalls-formula-0-injection-due-to-sterility-risks.
Source Summary by GovInfoNow · govinfonow.com/recall/43111-meditech-recalls-formula-0-injection-due-to-sterility-risks · Updated October 11, 2026 · FDA enforcement record: FDA #D-0807-2016
Cite this page
“Meditech Recalls Formula 0 Injection Due to Sterility Risks.” GovInfoNow, updated October 11, 2026. https://govinfonow.com/recall/43111-meditech-recalls-formula-0-injection-due-to-sterility-risks. Based on FDA recall #D-0807-2016 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0807-2016%22&limit=1).
Why it’s dangerous
The lack of assurance of sterility means the injection could be contaminated with microorganisms. Injecting non-sterile medication can lead to serious infections or other complications for the patient.
Who’s affected
Patients prescribed Formula 0 injection by healthcare providers are affected. Because the product is Rx only, it is used in medical settings or under strict prescription guidance.
How to tell if you have this one
Look for Formula 0 (PGE 20 mcg/mL) Injection in 5 mL vials manufactured by Meditech Laboratories, Inc. The recalled lot number is 020716-0 with an expiration date of 05/07/16.
- Brand
Meditech Laboratories- Category
Drug
All 7 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
- Classification
Class II- Status
Terminated- Distribution
Nationwide
| Recall number | Product, codes & lots |
|---|---|
| D-0802-2016 | Formula 2 (Papaverine 9 mg, Phentolamine 1 mg, Atropine 0.1 mg, PGE 10 mcg/mL) Injection, 5 mL vials, Rx only, Meditech Laboratories, Inc., 3200 Polaris Ave., Suite 27, Las Vegas, NV 89102.; Lot #: 110115-2, Exp 01/01/16 |
| D-0803-2016 | 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. .; Lot#: 022316-4, Exp 04/08/16 |
| D-0804-2016 | 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.; Lot#: 022416-9, Exp 04/09/16. |
| D-0805-2016 | 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.; Lot#: 011916-1, Exp 04/19/16; 020316-1, Exp 05/03/16 |
| D-0806-2016 | 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.; Lot#: 011716-3, Exp 04/17/16; 012416-3, Exp 04/24/16. |
| D-0807-2016 | Formula 0 (PGE 20 mcg/mL) Injection, 5 mL vials, Rx only, Meditech Laboratories, Inc., 3200 Polaris Ave., Suite 27, Las Vegas, NV 89102.; Lot#: 020716-0, Exp 05/07/16 |
| D-0808-2016 | Formula 2 (Papaverine 9 mg, Phentolamine 1 mg, Atropine 0.1 mg, PGE 10 mcg/mL), 5 mL vials, Meditech Laboratories, Inc., 3200 Polaris Ave., Suite 27, Las Vegas, NV 89102.; Lot #: 12216-2, Exp 04/22/16 |
What to do — step by step
Check Lot Numbers
Verify if your vials match lot number 020716-0 and expire on 05/07/16.
Contact Healthcare Provider
Consult your doctor or pharmacist immediately regarding the lack of sterility assurance and next steps.
Where it went and when
Where it was distributed
Distributed nationwide.
FDA distribution: “Nationwide” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA terminated this recall 3 months after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
Questions people ask
How many units are being recalled?
A total of 1320 vials across all formulas are included in this recall.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #D-0807-2016 (March 14, 2016) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0807-2016 to see it in context.
- Plain-language summary written by qwen3.6:35b-a3b on October 11, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.