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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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High RiskFDA Drug
Medications & Supplements/Prescription Drugs

Hiers Enterprises, LLC dba Northwest Compounding Pharmacy: Various Compounded Liquid Medications Recalled for Lack of Sterility

Agency Publication Date: January 3, 2019
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Summary

Approximately 2,125 units of various compounded medications, including cyclosporin, epinephrine, glutathione, and vitamin injections, have been recalled because they may lack sterility assurance. These products were distributed to three medical facilities, one physician's office, and 80 individual patients exclusively within the state of Oregon. Because these medications are intended to be sterile (such as eye drops and injections), a lack of sterility could lead to serious infections. Consumers should check their medication labels for the specific lot numbers and expiration dates provided in the recall notice.

Risk

If a medication intended for injection or use in the eyes is not sterile, it may contain microorganisms like bacteria or fungi that can cause severe, life-threatening infections at the site of administration or throughout the body.

What You Should Do

  1. Check your medication labels for any of the following products and lot numbers: Cyclosporin liquid (Lots 08172018@7, 09202018@16, 10172018@32, 07192018@12, 07272018@2, 10042018@10, 10122018@30, 11022018@18), Epinephrine (Lots 10102018@13, 10222018@33), Glutathione (Lots 10292018@17, 10092018@5), HCG (Lot 10162018@22), Hydroxyprogesterone (Lot 10252018@24), Lidocaine (Lots 10222018@15, 10222018@40), Lidocaine/Epinephrine (Lot 08072018@30), MIC B Vitamins (Lots 10192018@8, 10292018@15), Methocarbamol (Lots 10082018@34, 10312018@27), Testosterone Cypionate (Lot 10012018@54), or Vitamin B12 (Lots 10162018@28, 10182018@38).
  2. Immediately stop using any of the affected medications listed above.
  3. Contact your healthcare provider or pharmacist for guidance regarding alternative treatments and to report any adverse health effects.
  4. Return any unused portions of the recalled medication to Northwest Compounding Pharmacy for a refund.
  5. Contact Hiers Enterprises, LLC dba Northwest Compounding Pharmacy at 1350 Ne Stephens St Ste 42, Roseburg, Oregon, for further instructions on the return process.
  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

💰Full Refund

Drug product return for refund

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

Affected Products

Product: Cyclosporin liquid 2%, Rx, plastic dropper bottle (830 ml)
Model:
D-0392-2019
Lot Numbers:
08172018@7 (Exp 2/13/19)
09202018@16 (Exp 3/2/19)
10172018@32 (Exp 3/2/19)
Product: Epinephrine liquid 1:1000, RX, glass vial (50 ml)
Model:
D-0393-2019
Lot Numbers:
10102018@13 (Exp 1/8/19)
10222018@33 (Exp 1/20/19)
Product: Glutathione liquid, 100mg/ml (60 ml)
Model:
D-0394-2019
Lot Numbers:
10292018@17
Product: HCG liquid, 1000u/ml, RX, glass vial (30 ml)
Model:
D-0395-2019
Lot Numbers:
10162018@22
Product: Hydroxyprogesterone liquid, 250mg/ml, RX, glass vial (20 ml)
Model:
D-0396-2019
Lot Numbers:
10252018@24
Product: Lidocaine gel 2%, RX, plastic dropper (125 ml)
Model:
D-0397-2019
Lot Numbers:
10222018@15
Product: Lidocaine/Epinepherine liquid 1%/ 1:1000, RX, glass vial (50 ml)
Model:
D-0398-2019
Lot Numbers:
08072018@30
Product: MIC B vitamin liquid 25/50/50/1/1/1mg/ml RX glass vial (310 ml)
Model:
D-0399-2019
Lot Numbers:
10192018@8 (Exp 2/28/19)
10292018@15 (Exp 1/31/19)
Product: Methocarbamol liquid 100mg/ml, RX, glass vial (300 ml)
Model:
D-0400-2019
Lot Numbers:
10082018@34 (Exp 1/6/19)
10312018@27 (Exp 1/29/19)
Product: Testosteron Cypionate liquid 200mg/ml, RX, glass vial (200 ml)
Model:
D-0401-2019
Lot Numbers:
10012018@54 (Exp 3/30/19)
Product: Vitamin B12 liquid 1000mcg/ml, RX, glass vial (150 ml)
Model:
D-0402-2019
Lot Numbers:
10162018@28 (Exp 1/14/19)
10182018@38 (Exp 1/16/19)
Product: Cyclosporin liquid 1%, Rx, plastic dropper bottle
Model:
D-0403-2019
Lot Numbers:
07192018@12
Product: Cyclosporin liquid 0.5%, Rx, plastic dropper bottle
Model:
D-0404-2019
Lot Numbers:
07272018@2
Product: Cyclosporin liquid 0.2%, Rx, plastic dropper bottle
Model:
D-0405-2019
Lot Numbers:
10042018@10
Product: Cyclosporin liquid 0.05%, Rx, plastic dropper bottle
Model:
D-0406-2019
Lot Numbers:
10122018@30
11022018@18
Product: Glutathione liquid, 200mg/ml, Rx
Model:
D-0407-2019
Lot Numbers:
10092018@5
Product: Lidocaine gel 1%, RX, plastic dropper
Model:
D-0408-2019
Lot Numbers:
10222018@40

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 81883
Status: Resolved
Manufacturer: Hiers Enterprises, LLC dba Northwest Compounding Pharmacy
Sold By: Northwest Compounding Pharmacy; Physician's offices; Medical facilities
Manufactured In: United States
Units Affected: 11 products (830 ml; 50 ml; 60 ml; 30 ml; 20 ml; 125 ml; 50 ml; 310 ml; 300 ml; 200 ml; 150 ml)
Distributed To: Oregon
Agency Last Updated: January 27, 2019

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.

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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 · 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.