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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Drug
Medications & Supplements/Prescription Drugs

Ranier's Compounding Laboratory: Various Sterile Compounded Drugs Recalled Due to Lack of Sterility Assurance

Agency Publication Date: August 15, 2018
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Summary

Ranier's Compounding Laboratory is recalling 294 units of various compounded medications, including eye solutions, injectable treatments, and inhalation drugs, because they may not be sterile. The recall was initiated because the laboratory's manufacturing practices could not guarantee that products intended to be sterile were free from contamination. These products include common medications like Atropine and Avastin as well as specialized injections, and were distributed primarily within Pennsylvania.

Risk

If a drug intended for injection or use in the eye is not sterile, it can introduce bacteria or other contaminants directly into the body. This poses a significant risk of serious infections, which could lead to permanent organ damage or life-threatening complications.

What You Should Do

  1. Check your medication labels for 'Ranier's Rx Laboratory' and the address '1107 Lowry Avenue Suite A, Jeannette, PA 15644' to see if your product is affected.
  2. Identify if you have any of the specific affected products, including Atropine 0.01% (5 mL), Avastin 1.25 mg/0.05 mL syringes, Morphine Sulf inhalation 5mg/3cc, Vitamin D3 Injection, or various Prostaglandin/Papaverine/Phentolamine (Triple P) injections.
  3. Immediately stop using any of these medications that are currently within their expiration date, as all lots within the expiry period are included in this recall.
  4. Contact your healthcare provider or pharmacist immediately to discuss alternative treatments and to report any adverse effects you may have experienced.
  5. Return any unused portions of the recalled medication to the pharmacy where you received it for a refund and contact Ranier's Compounding Laboratory for further instructions.
  6. For additional questions or to report a complaint, contact the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls.

Your Remedy Options

๐Ÿ’ฐFull Refund

Drug recall baseline remedy

How to: Contact your healthcare provider or pharmacist for guidance. Return any unused product to the pharmacy for a refund

Affected Products

Product: Atropine 0.01% Opth Solution (5 mL droptainer)
Model:
D-1080-2018
Date Ranges: All lots within expiry
Product: DMSO 6.25% Opth Sol (10 mL droptainer)
Model:
D-1081-2018
Date Ranges: All lots within expiry
Product: Avastin 1.25 mg/0.05 mL (prefilled syringe)
Model:
D-1082-2018
Date Ranges: All lots within expiry
Product: Triple P (Prostaglandin/Papaverine/Phentolamine) Injection 0.008/22.5/0.83 mg/mL (5 mL and 10 mL vials)
Model:
D-1083-2018
Date Ranges: All lots within expiry
Product: PR/PA/PH (Prostaglandin/Papaverine/Phentolamine) Injection 10mcg/30/1mg/mL (10 mL vial)
Model:
D-1084-2018
Date Ranges: All lots within expiry
Product: Morphine Sulf inhalation 5mg/3cc (3cc vial)
Model:
D-1085-2018
Date Ranges: All lots within expiry
Product: Dehydrated Alcohol Solution (1 mL and 3 mL vials)
Model:
D-1086-2018
Date Ranges: All lots within expiry
Product: Vitamin D3 Injection 50,000 IU/mL (4 mL vial)
Model:
D-1087-2018
Date Ranges: All lots within expiry
Product: Medroxprogesterone 1% Ophthalmic Solution (10 mL droptainer)
Model:
D-1088-2018
Date Ranges: All lots within expiry
Product: Acetylcysteine 10% Oph Solution (10 mL droptainer)
Model:
D-1089-2018
Date Ranges: All lots with expiry
Product: P/P/P (Prostaglandin/Papaverine/Phentolamine) Injection 0.02/30/2 mg/mL (5 mL vial)
Model:
D-1090-2018
Date Ranges: All lots within expiry
Product: PRASH 12.2mcg/1.22m/19.29 (Prostaglandin/Phentolamine/Papaverine) Injection (10 mL vial)
Model:
D-1091-2018
Date Ranges: All lots within expiry
Product: PRO/PA/PH/AT 18mcg/1.8 mg/0.2 mg/0.02 mg/mL (Prostaglandin/Papaverine/Phentolamine/Atropine) Injection (10 mL vial)
Model:
D-1092-2018
Date Ranges: All lots within expiry
Product: P/P/P 0.02/40/2 mg/mL (Prostaglandin/Papaverine/Phentolamine) Injection (1 mL vial)
Model:
D-1093-2018
Date Ranges: All lots within expiry
Product: Papav 300/Phent 5mg/10mL (Papaverine/Phentolamine) Injection (10 mL vial)
Model:
D-1094-2018
Date Ranges: All lots within expiry

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 80633
Status: Resolved
Manufacturer: Ranier's Compounding Laboratory
Sold By: Ranier's Rx Laboratory; Direct distribution in Pennsylvania
Manufactured In: United States
Units Affected: 15 products (5 droptainers; 1 droptainer; 213 prefilled syringes; a) 1 vial; b) 1 vial; 1 vial; 60 vials; a) 2 vials; b) 1 vial; 2 vials; 1 droptainer; 1 droptainer; 2 vials; 1 vial; 1 vial; 1 vial; 2 vials)
Distributed To: Pennsylvania

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.