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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

Health Solutions Pharmacy Center Inc dba Professional Compounding Pharmacy: Sterile Compounded Drugs Recalled for Insanitary Processing Conditions

Agency Publication Date: April 9, 2019
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Summary

Health Solutions Pharmacy Center Inc, doing business as Professional Compounding Pharmacy, is recalling 165 units of various sterile compounded medications, including eye drops and injectable drugs. The recall was initiated after an FDA inspection found insanitary conditions and a lack of processing controls during the compounding process. While no specific injuries have been reported, the sterile drugs were produced in an environment that could lead to contamination. These products were dispensed in Oregon between September 1, 2018, and February 20, 2019.

Risk

The lack of sterile processing controls means these medications may be contaminated with microorganisms. Using contaminated eye drops or injectable drugs can lead to serious infections, which could result in vision loss or life-threatening systemic illness.

What You Should Do

  1. Check your medication labels for 'Professional Compounding Pharmacy' and the specific product names and lot numbers listed in this recall.
  2. Immediately stop using any of the affected products, including Sodium Chloride 5% eye drops, Dexamethasone eye drops, Acetyl-L-Cysteine eye drops, and various injectable medications like Papaverine, Phentolamine, and PGE1 blends.
  3. For eye drops, verify if you have Sodium Chloride 5% (Lot 12022019@30), Dexamethasone 0.1% (various lots including 23012019@48, 24012019@2, 24012019@36), or Acetyl-L-Cysteine 10% (various lots including 17012019@13, 30012019@36).
  4. For injectable drugs, check for Hydroxyprogesterone Caproate (Lots 01112018@19, 04012019@52) or various penile injection blends (Papaverine-Phentolamine-PGE1) with lot numbers such as 18092018@52, 05102018@36, and 17102018@15.
  5. Contact your healthcare provider or pharmacist immediately to discuss alternative treatments and to report any adverse effects you may have experienced.
  6. Return any unused product to Professional Compounding Pharmacy for a refund and contact the manufacturer at their Corvallis, Oregon location for further instructions.
  7. Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls for additional information.

Your Remedy Options

๐Ÿ’ฐFull Refund

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

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

Affected Products

Product: SODIUM CHLORIDE PRES-FREE 5% OPHTH STERILE SOLUTION (20ml)
Model:
Recall #: D-1086-2019
Lot Numbers:
12022019@30
12022019
Date Ranges: sold between 09-01-2018 to 02-20-2019
Product: DEXAMETHASONE (NAPO4) 0.1% OPHTH PRES-FREE SOLUTION (10ml)
Model:
Recall #: D-1087-2019
Lot Numbers:
23012019@48
24012019@2
24012019@36
28012019@35
29012019@13
05022019@5
11022019@13
12022019@20
19022019@1
19022019@6
19022019@57
19022019@61
Date Ranges: sold between 09-01-2018 to 02-20-2019
Product: ACETYL-L-CYSTEINE 10% P.F. OPHTH SOLUTION (10ml)
Model:
Recall #: D-1088-2019
Lot Numbers:
17012019@13
30012019@36
01022019@4
14022019@1
19022019@18
19022019@60
Date Ranges: sold between 09-01-2018 to 02-20-2019
Product: HYDROXYPROGESTERONE CAPROATE 250 MG/ML OIL INJECTABLE (9ml/10ml)
Model:
Recall #: D-1089-2019
Lot Numbers:
01112018@19
04012019@52
14022019@23
14012019@36
Date Ranges: sold between 09-01-2018 to 02-20-2019
Product: PAPAVERINE-PHENTOLAMINE-PGE1 22-0.8 MG-8 MCG/ML INJECTABLE (5ml/6ml/10ml)
Model:
Recall #: D-1090-2019
Lot Numbers:
18092018@52
01102018@9
05102018@36
08102018@11
102018@9
03102018@27
12102018@18
17102018@15
2102018@18
22102018@31
30102018@22
29102018@9
21112018@38
11122018@7
28122018@11
03012019@17
08012019@21
28082018@16
14092018@28
11012019@64
05022019@27
06022019@6
Date Ranges: sold between 09-01-2018 to 02-20-2019
Product: PGE1 40 MCG/ML INJECTABLE (5ml/6ml/9ml/10ml)
Model:
Recall #: D-1091-2019
Lot Numbers:
10102018@30
31102018@33
05112018@1
15012019@8
30012019@33
Date Ranges: sold between 09-01-2018 to 02-20-2019
Product: PGE1-LIDOCAINE 40 MCG-1% /ML INJECTABLE (9ml/10ml)
Model:
Recall #: D-1098-2019
Lot Numbers:
26092018@22
09102018@47
15102018@33
29112018@4
10122018@14
19122018@20
21122018@29
27122018@20
16012019@59
18012019@17
21012019@49
22012019@24
Date Ranges: sold between 09-01-2018 to 02-20-2019

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 82278
Status: Resolved
Manufacturer: Health Solutions Pharmacy Center Inc dba Professional Compounding Pharmacy
Sold By: Professional Compounding Pharmacy
Manufactured In: United States
Units Affected: 25 products (1 prescription 20ml solution; 12 prescriptions; 6 prescriptions 10ml dropper bottle; 4 prescriptions 9 & 10ml injectable; 64 prescriptions 5, 10, 6 mL injections; 5 prescriptions 5,10, 6, 9 ml injectable; 3 prescriptions 10, 9, ml injection; 13 prescription 5, 6, 9, 10 ml injection; 9 prescriptions 10, 9ml injection; 2 prescription 5ml injection; 2 prescription 5, 6.5 ml injection; 3 prescription 5, 10 ml injection; 25 prescriptions 10, 9, ml injectable; 1 prescription 9ml injectable; 1 prescription, 9ml injectable; 1 prescription, 5ml injectable; 1 prescription, 9ml injection; 2 pre4scriptions 10 ml injections; 1 prescription 9ml injection; 2 prescriptions, 5ml injection; 1 prescription, 18ml injection; 3 prescriptions, 5ml injectable; 1 prescription, 5ml injection; 1 prescription, 5ml; 1 prescription, 5ml injection)
Distributed To: Oregon

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.