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Medium RiskFDA Drug
Medications & Supplements/Prescription Drugs

Tri-Coast Pharmacy: Lack of Assurance of Sterility

Agency Publication Date: January 4, 2017
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Summary

Tri-Coast Pharmacy is recalling 17 vials of TriMix (Alprostadil/Phentolamine/Papaverine), a compounded injectable medication, that were produced between May 17, 2016, and November 17, 2016. The recall was initiated because the pharmacy cannot guarantee the sterility of these specific batches. Consumers should check their medication for lot codes 07282016G, 07082016E, or 07142016D.

Risk

A lack of sterility assurance in an injectable medication poses a significant risk of localized or systemic infection, as contaminants may have been introduced during the compounding process. No specific injuries have been reported, but the risk remains medium due to the invasive nature of the drug's administration.

What You Should Do

  1. Check your TriMix (Alprostadil/Phentolamine/Papaverine 40mcg/2mg/60mg/mL) 1 ML vials for the following lot codes and expiration dates: 07282016G (Exp 09/08/2016), 07082016E (Exp 08/22/2016), or 07142016D (Exp 08/22/2016).
  2. Identify if you received any sterile products compounded by Tri-Coast Pharmacy between the dates of 05/17/2016 and 11/17/2016.
  3. Contact Tri-Coast Pharmacy or your healthcare provider immediately for instructions on how to handle the affected medication.
  4. Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) if you have further questions or wish to report an adverse event.

Affected Products

Product: TriMix, Alprostadil/Phentolamine/Papaverine 40mcg/2mg/60mg/mL, (1 ML)
Lot Numbers:
07282016G (Exp 09/08/2016)
07082016E (Exp 08/22/2016)
07142016D (Exp 08/22/2016)
Date Ranges: 05/17/2016 - 11/17/2016, 09/08/2016, 08/22/2016

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 75763
Status: Active
Manufacturer: Tri-Coast Pharmacy
Manufactured In: United States
Units Affected: 80 products (59 vials; 105 vials; 201 vials; 265 vials; 67 vials; 28 vials; 5 vials; 2 vials; 12 vials; 10 vials; 5 vials; 114 vials; 30 vials; 12 vials; 367 vials; 4,884 vials; 1,304 vials; 5,229 vials; 161 vials; 132 vials; 41 vials; 14 vials; 50 vials; 69 vials; 987 vials; 236 vials; 1,458 vials; 99 vials; 66 vials; 21 vials; 278 vials; 36 vials; 701 vials; 3 vials; 5 vials; 2 vials; 10 vials; 10 vials; 5 vials; 5 vials; 17 vials; 260 vials; 54 vials; 91 vials; 7 vials; 188 vials; 441 vials; 2116 vials; 920 vials; 127 vials; 90 vials; 166 vials; 400 vials; 2,818 vials; 7,168 vials; 1,544 vials; 1,244 vials; 152 vials; 882 vials; 1,567 vials; 13 vials; 347 vials; 78 vials; 17 vials; 9 vials; 35 vials; 18 vials; 25 vials; 8 vials; 141 vials; 13 vials; 5 vials; 17 vials; 17 vials; 2 units; 79 vials; 870 vials; 123 vials; 874 vials; 662 vials)

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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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 · 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.