Medications & Supplements/Prescription Drugs

Advanced Pharma Inc.: Various Injectable Medications Recalled for Lack of Sterility Assurance

Agency Publication Date: March 21, 2019

Summary

Advanced Pharma Inc. (operating as Avella of Houston) is recalling approximately 64,995 units of various injectable medications, including Hydromorphone, Fentanyl, Midazolam, and Morphine, due to concerns that the products may not be sterile. The recall affects 19 different types of medications packaged in sterile single-use syringes and bags distributed nationwide. Using a non-sterile injectable medication can lead to serious, life-threatening infections, particularly in hospitalized or vulnerable patients.

Risk

If an injectable drug is not sterile, it can introduce bacteria or fungi directly into a patient's bloodstream or tissue, potentially causing severe systemic infections or sepsis. No specific injuries have been reported in this data, but the lack of sterility assurance poses a significant health risk.

What You Should Do

Check your medical supplies for any of the 19 affected injectable products from Avella of Houston, specifically looking for NDC codes such as 42852-289-67 (Hydromorphone), 42852-210-10 (Fentanyl), 42852-401-05 (Midazolam), or 42852-241-63 (Morphine).
Verify the lot numbers and expiration dates on the product labels; for example, Hydromorphone lot 12/03/18 4090 28967S (Exp. 4/2/2019) or Fentanyl lot 01/03/19 1311 21010P (Exp. 5/3/2019).
Immediately stop using any affected medication and quarantine the product to ensure it is not administered to patients.
Contact your healthcare provider or pharmacist immediately if you have been administered any of these products and have concerns about your health.
Return any unused product to the pharmacy or place of purchase for a refund and contact Advanced Pharma Inc. (Avella of Houston) at 877-794-0404 for further instructions on returning the recalled items.
For additional questions regarding this recall, contact the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA).

Your Remedy Options

Full Refund

Drug Refund

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

Affected Products

Product: HYDROmorphone HCl 1 mg in 0.9% Sodium Chloride, QS 5 mL Injectable Solution 1 mg/5 mL (0.2 mg per mL)

Model:

NDC: 42852-289-67

Lot Numbers:

12/03/18 4090 28967S (Exp. 4/2/2019)

12/03/18 6221 28967S (Exp. 4/2/2019)

Product: fentaNYL 1000 mcg/100 mL Injectable Solution Fentanyl 0.9% Sodium Chloride, QS, 100 mL

Model:

NDC: 42852-210-10

Lot Numbers:

01/03/19 1311 21010P (Exp. 5/3/2019)

Product: fentaNYL 2500 mcg/250 mL Injectable Solution, Fentanyl 0.9% Sodium Chloride, QS

Model:

NDC: 42852-210-25

Lot Numbers:

01/03/19 1645 21025P (Exp. 5/3/2019)

Product: Midazolam Benzodiazepine 50 mg/50 mL (1 mg/mL) Injectable Solution, Midazolam HCl 0.9% Sodium Chloride, QS

Model:

NDC: 42852-401-05

Lot Numbers:

12/03/18 9479 40105P (Exp. 4/2/2019)

12/3/18 6583 40105P (Exp. 4/2/2019)

12/3/18 8918 40105P (Exp. 4/2/2019)

12/03/18 4727 40105P (Exp. 4/2/2019)

Product: Phenylephrine HCl, 500 mcg in 0.9% Sodium Chloride, QS 5 mL Injectable Solution 500 mcg/5 mL (100 mcg per mL)

Model:

NDC: 42852-830-67

Lot Numbers:

01/18/19 3261 83067S (Exp. 6/17/2019)

10/18/18 0212 83067S (Exp. 3/17/2019)

10/23/18 7704 83067S (Exp. 3/22/2019)

11/02/18 5909 83067S (Exp. 4/1/2019)

10/31/18 8995 83067S (Exp. 3/30/2019)

10/22/18 2570 83067S (Exp. 3/21/2019)

10/18/18 6471 83067S (Exp. 3/17/2019)

11/05/18 5527 83067S (Exp. 4/4/2019)

11/05/18 0985 83067S (Exp. 4/4/2019)

10/22/18 9234 83067S (Exp. 3/21/2019)

10/30/18 6678 83067S (Exp. 3/29/2019)

Product: Glycopyrrolate Injectable Solution 1 mg/5 mL (0.2 mg per mL)

Model:

NDC: 42852-828-67

Lot Numbers:

12/05/18 0710 82867S (Exp. 5/4/2019)

10/24/18 0014 82867S (Exp. 3/23/2019)

11/01/18 8800 82867S (Exp. 3/31/2019)

Product: Phenylephrine HCl, 400 mcg in 0.9% Sodium Chloride, QS 10 mL Injectable Solution 400 mcg/10 mL (40 mcg per mL)

Model:

NDC: 42852-876-61

Lot Numbers:

10/18/18 1430 87661S (Exp. 3/17/2019)

10/29/18 1805 87661S (Exp. 3/28/2019)

Product: Phenylephrine HCl, 1 mg in 0.9% Sodium Chloride, QS 10 mL Injectable Solution 1 mg/10 mL (100 mcg per mL)

Model:

NDC: 42852-830-61

Lot Numbers:

10/24/18 3318 83061S (Exp. 3/23/2019)

10/18/18 3354 83061S (Exp. 3/17/2019)

10/23/2018 6050 83061S (Exp. 3/22/2019)

10/23/18 8105 83061S (Exp. 3/22/2019)

10/18/18 1961 83061S (Exp. 3/17/2019)

10/18/18 2598 83061S (Exp. 3/17/2019)

11/05/18 1184 83061S (Exp. 4/4/2019)

10/22/18 0737 83061S (Exp. 3/21/2019)

10/25/18 1198 83061S (Exp. 3/24/2019)

11/06/18 4451 83061S (Exp. 4/5/2019)

11/06/18 0108 83061S (Exp. 4/5/2019)

10/22/18 1530 83061S (Exp. 3/21/2019)

Product: Neostigmine Methylsulfate Injection Solution 5 mg/5mL (1 mg per mL)

Model:

NDC: 42852-829-67

Lot Numbers:

11/02/18 9350 82967S (Exp. 4/1/2019)

10/23/18 1471 82967S (Exp. 3/22/2019)

10/24/18 4412 82967S (Exp. 3/23/2019)

10/24/18 0733 82967S (Exp. 3/22/2019)

Product: Glycopyrrolate 0.6 mg/3 mL (0.2 mg per mL) Injectable Solution

Model:

NDC: 42852-828-22

Lot Numbers:

10/31/18 2288 82822S (Exp. 3/30/2019)

10/18/18 8371 82822S (Exp. 3/17/2019)

Product: 2% Lidocaine HCl Injectable Solution, 60 mg/3 mL (20 mg per mL)

Model:

NDC: 42852-011-22

Lot Numbers:

10/18/18 2217 01122S (Exp. 3/17/2019)

Product: 2% Lidocaine HCl Injectable Solution, 100 mg/5 mL (20 mg per mL)

Model:

NDC: 42852-011-67

Lot Numbers:

10/19/18 1990 01167S (Exp. 3/18/2019)

Product: Phenylephrine HCl, 800 mcg in 0.9% Sodium Chloride, QS 10 mL Injectable Solution, 800 mcg/10 mL (80 mcg per mL)

Model:

NDC: 42852-865-61

Lot Numbers:

10/17/18 2976 86561S (Exp. 3/16/2019)

Product: Esmolol HCl Injectable Solution 100 mg/10 mL (10 mg per mL)

Model:

NDC: 42852-827-61

Lot Numbers:

11/06/18 5007 82761S (Exp. 4/5/2019)

Product: Heparin 10 Units/10 mL 10 Units in 0.45% Sodium Chloride, QS 10 mL, Injectable Solution, Dwell

Model:

NDC: 42852-725-61

Lot Numbers:

10/23/18 1998 72561SPF (Exp. 3/22/2019)

Product: Heparin 5,000 Units/5mL (1,000 Units per mL) Injectable Solution, 5,000 Units in 0.9% Sodium Chloride, QS 5 mL

Model:

NDC: 42852-739-67

Lot Numbers:

10/25/18 4819 73967S (Exp. 3/24/2019)

Product: Phenylephrine HCl, 1 mg in Sterile Water for Injection, QS 10 mL Injectable Solution 1 mg/10 mL (100 mcg per mL)

Model:

NDC: 42852-802-61

Lot Numbers:

11/01/18 8847 80261S (Exp. 3/31/2019)

Product: Morphine Sulfate 30 mg/30 mL (1 mg/mL) Injectable Solution Morphine Sulfate 30 mg 0.9% Sodium Chloride QS 30 mL

Model:

NDC: 42852-241-63

Lot Numbers:

10/19/18 2117 24163M (Exp. 3/18/2019)

11/5/18 1363 24163M (Exp. 4/4/2019)

11/5/18 1511 24163M (Exp. 4/4/2019)

10/19/18 2061 24163M (Exp. 3/18/2019)

10/23/18 1963 14163M (Exp. 3/22/2019)

10/19/18 1441 24163M (Exp. 3/18/2019)

Product: Phenylephrine HCl, 1,200 mcg in 0.9% Sodium Chloride, QS 10 mL Injectable Solution 1,200 mcg/10 mL (120 mcg per mL)

Model:

NDC: 42852-882-61

Lot Numbers:

11/05/18 7020 88261S (Exp. 4/4/2019)

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 82398

Status: Resolved

Manufacturer: Advanced Pharma Inc.

Sold By: Avella of Houston

Manufactured In: United States

Units Affected: 19 products (2400 syringes; 360 bags; 180 bags; 1125 bags; 16075 syringes; 2580 syringes; 1575 syringes; 22900 syringes; 5700 syringes; 140 syringes; 1540 syringes; 1980 syringes; 800 syringes; 550 syringes; 500 syringes; 1440 syringes; 1850 syringes; 2325 syringes; 975)

Distributed To: Nationwide

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 · 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.

Summary

Risk

What You Should Do

Check your medical supplies for any of the 19 affected injectable products from Avella of Houston, specifically looking for NDC codes such as 42852-289-67 (Hydromorphone), 42852-210-10 (Fentanyl), 42852-401-05 (Midazolam), or 42852-241-63 (Morphine).

Verify the lot numbers and expiration dates on the product labels; for example, Hydromorphone lot 12/03/18 4090 28967S (Exp. 4/2/2019) or Fentanyl lot 01/03/19 1311 21010P (Exp. 5/3/2019).

Immediately stop using any affected medication and quarantine the product to ensure it is not administered to patients.

Contact your healthcare provider or pharmacist immediately if you have been administered any of these products and have concerns about your health.

Return any unused product to the pharmacy or place of purchase for a refund and contact Advanced Pharma Inc. (Avella of Houston) at 877-794-0404 for further instructions on returning the recalled items.

For additional questions regarding this recall, contact the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA).

Affected Products

Product: HYDROmorphone HCl 1 mg in 0.9% Sodium Chloride, QS 5 mL Injectable Solution 1 mg/5 mL (0.2 mg per mL)

Model:

NDC: 42852-289-67

Lot Numbers:

12/03/18 4090 28967S (Exp. 4/2/2019)

12/03/18 6221 28967S (Exp. 4/2/2019)

Product: fentaNYL 1000 mcg/100 mL Injectable Solution Fentanyl 0.9% Sodium Chloride, QS, 100 mL

Model:

NDC: 42852-210-10

Lot Numbers:

01/03/19 1311 21010P (Exp. 5/3/2019)

Product: fentaNYL 2500 mcg/250 mL Injectable Solution, Fentanyl 0.9% Sodium Chloride, QS

Model:

NDC: 42852-210-25

Lot Numbers:

01/03/19 1645 21025P (Exp. 5/3/2019)

Product: Midazolam Benzodiazepine 50 mg/50 mL (1 mg/mL) Injectable Solution, Midazolam HCl 0.9% Sodium Chloride, QS

Model:

NDC: 42852-401-05

Lot Numbers:

12/03/18 9479 40105P (Exp. 4/2/2019)

12/3/18 6583 40105P (Exp. 4/2/2019)

12/3/18 8918 40105P (Exp. 4/2/2019)

12/03/18 4727 40105P (Exp. 4/2/2019)

Product: Phenylephrine HCl, 500 mcg in 0.9% Sodium Chloride, QS 5 mL Injectable Solution 500 mcg/5 mL (100 mcg per mL)

Model:

NDC: 42852-830-67

Lot Numbers:

01/18/19 3261 83067S (Exp. 6/17/2019)

10/18/18 0212 83067S (Exp. 3/17/2019)

10/23/18 7704 83067S (Exp. 3/22/2019)

11/02/18 5909 83067S (Exp. 4/1/2019)

10/31/18 8995 83067S (Exp. 3/30/2019)

10/22/18 2570 83067S (Exp. 3/21/2019)

10/18/18 6471 83067S (Exp. 3/17/2019)

11/05/18 5527 83067S (Exp. 4/4/2019)

11/05/18 0985 83067S (Exp. 4/4/2019)

10/22/18 9234 83067S (Exp. 3/21/2019)

10/30/18 6678 83067S (Exp. 3/29/2019)

Product: Glycopyrrolate Injectable Solution 1 mg/5 mL (0.2 mg per mL)

Model:

NDC: 42852-828-67

Lot Numbers:

12/05/18 0710 82867S (Exp. 5/4/2019)

10/24/18 0014 82867S (Exp. 3/23/2019)

11/01/18 8800 82867S (Exp. 3/31/2019)

Product: Phenylephrine HCl, 400 mcg in 0.9% Sodium Chloride, QS 10 mL Injectable Solution 400 mcg/10 mL (40 mcg per mL)

Model:

NDC: 42852-876-61

Lot Numbers:

10/18/18 1430 87661S (Exp. 3/17/2019)

10/29/18 1805 87661S (Exp. 3/28/2019)

Product: Phenylephrine HCl, 1 mg in 0.9% Sodium Chloride, QS 10 mL Injectable Solution 1 mg/10 mL (100 mcg per mL)

Model:

NDC: 42852-830-61

Lot Numbers:

10/24/18 3318 83061S (Exp. 3/23/2019)

10/18/18 3354 83061S (Exp. 3/17/2019)

10/23/2018 6050 83061S (Exp. 3/22/2019)

10/23/18 8105 83061S (Exp. 3/22/2019)

10/18/18 1961 83061S (Exp. 3/17/2019)

10/18/18 2598 83061S (Exp. 3/17/2019)

11/05/18 1184 83061S (Exp. 4/4/2019)

10/22/18 0737 83061S (Exp. 3/21/2019)

10/25/18 1198 83061S (Exp. 3/24/2019)

11/06/18 4451 83061S (Exp. 4/5/2019)

11/06/18 0108 83061S (Exp. 4/5/2019)

10/22/18 1530 83061S (Exp. 3/21/2019)

Product: Neostigmine Methylsulfate Injection Solution 5 mg/5mL (1 mg per mL)

Model:

NDC: 42852-829-67

Lot Numbers:

11/02/18 9350 82967S (Exp. 4/1/2019)

10/23/18 1471 82967S (Exp. 3/22/2019)

10/24/18 4412 82967S (Exp. 3/23/2019)

10/24/18 0733 82967S (Exp. 3/22/2019)

Product: Glycopyrrolate 0.6 mg/3 mL (0.2 mg per mL) Injectable Solution

Model:

NDC: 42852-828-22

Lot Numbers:

10/31/18 2288 82822S (Exp. 3/30/2019)

10/18/18 8371 82822S (Exp. 3/17/2019)

Product: 2% Lidocaine HCl Injectable Solution, 60 mg/3 mL (20 mg per mL)

Model:

NDC: 42852-011-22

Lot Numbers:

10/18/18 2217 01122S (Exp. 3/17/2019)

Product: 2% Lidocaine HCl Injectable Solution, 100 mg/5 mL (20 mg per mL)

Model:

NDC: 42852-011-67

Lot Numbers:

10/19/18 1990 01167S (Exp. 3/18/2019)

Product: Phenylephrine HCl, 800 mcg in 0.9% Sodium Chloride, QS 10 mL Injectable Solution, 800 mcg/10 mL (80 mcg per mL)

Model:

NDC: 42852-865-61

Lot Numbers:

10/17/18 2976 86561S (Exp. 3/16/2019)

Product: Esmolol HCl Injectable Solution 100 mg/10 mL (10 mg per mL)

Model:

NDC: 42852-827-61

Lot Numbers:

11/06/18 5007 82761S (Exp. 4/5/2019)

Product: Heparin 10 Units/10 mL 10 Units in 0.45% Sodium Chloride, QS 10 mL, Injectable Solution, Dwell

Model:

NDC: 42852-725-61

Lot Numbers:

10/23/18 1998 72561SPF (Exp. 3/22/2019)

Product: Heparin 5,000 Units/5mL (1,000 Units per mL) Injectable Solution, 5,000 Units in 0.9% Sodium Chloride, QS 5 mL

Model:

NDC: 42852-739-67

Lot Numbers:

10/25/18 4819 73967S (Exp. 3/24/2019)

Product: Phenylephrine HCl, 1 mg in Sterile Water for Injection, QS 10 mL Injectable Solution 1 mg/10 mL (100 mcg per mL)

Model:

NDC: 42852-802-61

Lot Numbers:

11/01/18 8847 80261S (Exp. 3/31/2019)

Product: Morphine Sulfate 30 mg/30 mL (1 mg/mL) Injectable Solution Morphine Sulfate 30 mg 0.9% Sodium Chloride QS 30 mL

Model:

NDC: 42852-241-63

Lot Numbers:

10/19/18 2117 24163M (Exp. 3/18/2019)

11/5/18 1363 24163M (Exp. 4/4/2019)

11/5/18 1511 24163M (Exp. 4/4/2019)

10/19/18 2061 24163M (Exp. 3/18/2019)

10/23/18 1963 14163M (Exp. 3/22/2019)

10/19/18 1441 24163M (Exp. 3/18/2019)

Product: Phenylephrine HCl, 1,200 mcg in 0.9% Sodium Chloride, QS 10 mL Injectable Solution 1,200 mcg/10 mL (120 mcg per mL)

Model:

NDC: 42852-882-61

Lot Numbers:

11/05/18 7020 88261S (Exp. 4/4/2019)

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 82398

Status: Resolved

Manufacturer: Advanced Pharma Inc.

Sold By: Avella of Houston

Manufactured In: United States

Distributed To: Nationwide