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Medium RiskFDA Drug
Medications & Supplements/Prescription Drugs

Assurance Infusion: Various Compounded Injectable and Ophthalmic Drugs Recalled for Sterility Issues

Agency Publication Date: January 13, 2020
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Summary

Assurance Infusion is recalling 2,535 units of various compounded medications, including Alprostadil, Autologous Serum eye drops, and numerous pain management injections like Morphine, Fentanyl, and Hydromorphone. These products are being recalled because the company cannot guarantee they are sterile. The recall affects a wide range of injectable solutions in vials and syringes distributed nationwide between 2019 and early 2020. Consumers should immediately stop using any affected medication and contact their healthcare provider to discuss alternative treatments.

Risk

Using a drug intended to be sterile that is not sterile can lead to life-threatening infections at the site of injection or in the blood. While no specific injuries were reported in this notice, the lack of sterility assurance poses a significant health risk to patients receiving these medications.

What You Should Do

  1. Check your medication packaging for the manufacturer name 'Assurance Infusion' and the specific product names and lot numbers listed in the recall.
  2. Identify your specific lot number and expiration date, such as Alprostadil Lot 09262019@13 (Exp 03/24/2020) or Trimix Lot 07082019@29 (Exp 01/04/2020). There are over 100 distinct lot codes involved.
  3. Stop using any recalled medication immediately to avoid the risk of infection from potentially non-sterile products.
  4. Contact your doctor, pharmacist, or healthcare provider right away to inform them you have a recalled product and to seek advice on a replacement medication.
  5. Return any unused product to the place of purchase or pharmacy for a refund and further instructions on safe disposal.
  6. If you have questions for the manufacturer, contact Assurance Infusion at (713) 533-8800.
  7. For general consumer safety questions, contact the FDA Consumer Complaint hotline at 1-888-723-3332 or visit www.fda.gov/safety/recalls.

Your Remedy Options

💰Full Refund

Refund for unused product.

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

Affected Products

Product: Alprostadil 40 mcg/mL Inj. Soln. (2 mL vial)
Model:
D-0662-2020
Lot Numbers:
09262019@13 (Exp. 03/24/2020)
10072019@03/04/2020
12062019@2 (Exp. 06/03/2020)
12172019@12 (Exp. 01/31/2020)
08142019@20 (Exp. 02/10/2020)
Product: Autologous Serum 20% Eye Drops (3 mL dropper)
Model:
D-0663-2020
Lot Numbers:
12092019@33 (Exp. 03/08/2020)
11112019@30 (Exp. 02/09/2020)
10012019@17 (Exp. 12/30/2019)
10162019@18 (Exp. 01/14/2020)
10252019@11 (Exp. 01/23/2020)
Product: BAC 150 mcg/BUP 2 mg/Hydrom 15 mg/Morp 20 mg/SUF 650 mcg/mL Inj. (20 mL syringe)
Model:
D-0664-2020
Lot Numbers:
12172019@2 (Exp. 12/26/2019)
Product: BAC 15MCG/HYDROM 15MG/ML INJ (20 mL syringe)
Model:
D-0665-2020
Lot Numbers:
12112019@23 (Exp. 12/20/2019)
Product: BAC 160MCG/HYDROM 16MG/ML INJ (20 mL syringe)
Model:
D-0666-2020
Lot Numbers:
12112019@20 (Exp. 12/20/2019)
Product: BAC 200MCG/ CLONI 250MCG/ MORP 10MG/ML INJ (20 mL syringe)
Model:
D-0667-2020
Lot Numbers:
12102019@8 (Exp. 12/19/2019)
Product: BAC 200MCG/BUP22MG/CLON210MCG/HYDROM 15MG/SUF800MCG/ML INJ (20 mL syringe)
Model:
D-0668-2020
Lot Numbers:
12172019@3 (Exp. 12/26/2019)
Product: BAC 225MCG/ BUP 4.5MG/ CLON 9MCG/ MORP 3MG/ML INJ (20 mL syringe)
Model:
D-0669-2020
Lot Numbers:
12112019@7 (Exp. 12/20/2019)
Product: BAC 2400MCG/ FENT 2600MCG/ MORP 3600MCG/ML INJ (20 mL syringe)
Model:
D-0670-2020
Lot Numbers:
12102019@2 (Exp. 12/19/2019)
Product: BAC 250MCG/ /FENT 3500MCG/ /MORP 25MG/ML INJ (20 mL syringe)
Model:
D-0671-2020
Lot Numbers:
12172019@6 (Exp. 12/26/2019)
Product: BAC 4000MCG /FENT 600MCG/ML INJ (20 mL syringe)
Model:
D-0672-2020
Lot Numbers:
12162019@16 (Exp. 12/25/2019)
Product: BAC 400MCG/BUP 20MG/HYDROM 15MG/SUF 1000MCG/ML INJ (20 mL syringe)
Model:
D-0673-2020
Lot Numbers:
12202019@2 (Exp. 12/20/2019)
Product: BAC 50MCG/ HYDROM 10MG/ML INJ (20 mL syringe)
Model:
D-0674-2020
Lot Numbers:
12112019@27 (Exp. 12/20/2019)
Product: BAC 800MCG/BUP 6.7MG/CLON 600 MCG/FENT 850MCG/MORP 20MG INJ (20 mL syringe)
Model:
D-0675-2020
Lot Numbers:
12162019@2 (Exp. 12/25/2019)
Product: BACLOFEN 2000MCG/ML (40) INJ (20 mL syringe)
Model:
D-0676-2020
Lot Numbers:
12112019@18 (Exp. 12/20/2019)
Product: Bi-Mix 30 mg/1 mg/mL Inj. (1 mL vial)
Model:
D-0677-2020
Lot Numbers:
09192019@19 (Exp. 03/17/2020)
08162019@5 (Exp. 02/12/2020)
Product: Bi-Mix Forte 30 mg/2 mg/mL Inj. (1 mL vial)
Model:
D-0678-2020
Lot Numbers:
07302019@15 (Exp. 01/29/2020)
Product: BPC-157 2000 mcg/mL (5 mL vial)
Model:
D-0679-2020
Lot Numbers:
11132019@15 (Exp. 02/11/2020)
12112019@25 (Exp. 02/13/2020)
11202019@9 (Exp. 02/13/2020)
Product: BUP 10MG/ FENT 1000MCG/ML INJ (20 mL syringe)
Model:
D-0680-2020
Lot Numbers:
12162019@29 (Exp. 12/25/2019)
Product: BUP 10MG/HYDROM 10MG/MORP 2MG/SUF 250MCG/ML INJ (20 mL syringe)
Model:
D-0681-2020
Lot Numbers:
12112019@8 (Exp. 12/20/2019)
Product: BUP 10MG/HYDROM 15MG/SUF 200MCG/ML INJ (20 mL syringe)
Model:
D-0682-2020
Lot Numbers:
12162019@4 (Exp. 12/25/2019)
Product: BUP 15MG/CLON 300MCG/ FENT 1500MCG/ML(40) INJ (20 mL syringe)
Model:
D-0683-2020
Lot Numbers:
12122019@6 (Exp. 12/21/2019)
Product: BUP 15MG/CLON 400MCG/ FENT 6000MCG/ML INJ (20 mL syringe)
Model:
D-0684-2020
Lot Numbers:
12132019@5 (Exp. 12/22/2019)
Product: BUP 15MG/CLON 600MCG/MORP 30MG/ML (40) INJ (20 mL syringe)
Model:
D-0685-2020
Lot Numbers:
12182019@2 (Exp. 12/27/2019)
Product: BUP 15MG/HYDROM 5MG/ML INJ (20 mL syringe)
Model:
D-0686-2020
Lot Numbers:
12122019@20 (Exp. 12/21/2019)
Product: BUP 17MG/MORP 22MG/ML INJ (20 mL syringe)
Model:
D-0687-2020
Lot Numbers:
12122019@25 (Exp. 12/21/2019)
Product: BUP 1MG/ML/HYDROM 7MG INJ (20 mL syringe)
Model:
D-0688-2020
Lot Numbers:
12112019@10 (Exp. 12/20/2019)
Product: BUP 2.5MG/ CLONI 5MCG/ FENT 200MCG/ SUF 50MCG/ML (40) INJ (20 mL syringe)
Model:
D-0689-2020
Lot Numbers:
12122019@4 (Exp. 12/21/2019)
Product: BUP 2.5MG/FENT 25MCG/HYDRO 2MG/MORP 40MG/ML (20 mL syringe)
Model:
D-0690-2020
Lot Numbers:
12102019@3 (Exp. 12/19/2019)
Product: BUP 20MG/CLON 250MCG/FENT 7200MCG/ML INJ (20 mL syringe)
Model:
D-0691-2020
Lot Numbers:
12172019@5 (Exp. 12/26/2019)
Product: BUP 20MG/CLON 300MCG/FENT 2000MCG/ML INJ (20 mL syringe)
Model:
D-0692-2020
Lot Numbers:
12122019@28 (Exp. 12/21/2019)
Product: BUP 20MG/SUF 1000MCG/ML INJ (20 mL syringe)
Model:
D-0693-2020
Lot Numbers:
12172019@10 (Exp. 12/26/2019)
Product: BUP 20MG/SUF 105MCG/ML INJ (20 mL syringe)
Model:
D-0694-2020
Lot Numbers:
12122019@8 (Exp. 12/21/2019)
Product: BUP 21MG/CLON 252MCG/MORP 20MG/ML INJ (20 mL syringe)
Model:
D-0695-2020
Lot Numbers:
12182019@1 (Exp. 12/27/2019)
Product: BUP 23MG/HYDROM 25MG/SUF 100MCG/ML INJ (20 mL syringe)
Model:
D-0696-2020
Lot Numbers:
12162019@15 (Exp. 12/25/2019)
Product: BUP 2MG/ HYDROM 2MG/ML INJ (20 mL syringe)
Model:
D-0697-2020
Lot Numbers:
12162019@10 (Exp. 12/25/2019)
Product: BUP 3.5MG/ HYDROM 4MG/ML INJ (20 mL syringe)
Model:
D-0698-2020
Lot Numbers:
12122019@27 (Exp. 12/21/2019)
Product: BUP 30MG/ FENT 400MCG/ML INJ (20 mL syringe)
Model:
D-0699-2020
Lot Numbers:
12132019@3 (Exp. 12/22/2019)
Product: BUP 30MG/ HYDROM 10MG/ML INJ (20 mL syringe)
Model:
D-0700-2020
Lot Numbers:
12122019@23 (Exp. 12/21/2019)
Product: BUP 30MG/ MORP 8MG/ML INJ (20 mL syringe)
Model:
D-0701-2020
Lot Numbers:
12122019@11 (Exp. 12/21/2019)
Product: BUP 30MG/FENT 750MCG/HYDROM 15MG/ML (40) INJ (20 mL syringe)
Model:
D-0702-2020
Lot Numbers:
12202019@1 (Exp. 12/20/2019)
Product: BUP 35MG/FENT 1.5MG/ML (20 mL syringe)
Model:
D-0703-2020
Lot Numbers:
12112019@17 (Exp. 12/20/2019)
Product: BUP 35MG/MORP 10MG/ML INJ (20 mL syringe)
Model:
D-0704-2020
Lot Numbers:
12162019@18 (Exp. 12/25/2019)
Product: BUP 3MG/HYDROM 15MG/ML INJ (20 mL syringe)
Model:
D-0705-2020
Lot Numbers:
12162019@1 (Exp. 12/25/2019)
Product: BUP 3 mg/MORP 15 mg/mL Inj. (20 mL syringe)
Model:
D-0706-2020
Lot Numbers:
12162019@28 (Exp. 12/25/2019)
12102019@1 (Exp. 12/19/2019)
Product: BUP 40MG/FENT 1200MCG/SUF 400MCG/ML INJ (20 mL syringe)
Model:
D-0707-2020
Lot Numbers:
12102019@4 (Exp. 12/19/2019)
Product: BUP 40MG/FENT 3000MCG/ML INJ (20 mL syringe)
Model:
D-0708-2020
Lot Numbers:
12102019@5 (Exp. 12/19/2019)
Product: BUP 40MG/MORP 4MG/ML INJ (20 mL syringe)
Model:
D-0709-2020
Lot Numbers:
12172019@4 (Exp. 12/26/2019)
Product: BUP 4MG/FENT 3000MCG/ML INJ (20 mL syringe)
Model:
D-0710-2020
Lot Numbers:
12182019@7 (Exp. 12/27/2019)
Product: BUP 5.3MG/ FENT 1050 MCG/ML INJ (20 mL syringe)
Model:
D-0711-2020
Lot Numbers:
12112019@5 (Exp. 12/20/2019)
Product: BUP 5MG/ HYDROM 15MG/ SUF 600MCG/ML (40ML) INJ (20 mL syringe)
Model:
D-0712-2020
Lot Numbers:
12102019@6 (Exp. 12/19/2019)
Product: BUP 5MG/HYDROM 5MG/ML INJ (20 mL syringe)
Model:
D-0713-2020
Lot Numbers:
12122019@26 (Exp. 12/21/2019)
Product: BUP 5MG/MORP 10MG/ML INJ (20 mL syringe)
Model:
D-0714-2020
Lot Numbers:
12122019@21 (Exp. 12/21/2019)
Product: BUP 5MG/MORP 20MG/ML INJ (20 mL syringe)
Model:
D-0715-2020
Lot Numbers:
12162019@6 (Exp. 12/25/2019)
Product: BUP 675MCG/MORP 20MG/ML INJ (20 mL syringe)
Model:
D-0716-2020
Lot Numbers:
12122019@12 (Exp. 12/21/2019)
Product: BUP 7MG/HYDROM 20MG/ML INJ (20 mL syringe)
Model:
D-0717-2020
Lot Numbers:
12182019@4 (Exp. 12/27/2019)
Product: BUP 8MG/CLON 100MCG/HYDROM 20MG/ML INJ (20 mL syringe)
Model:
D-0718-2020
Lot Numbers:
12122019@5 (Exp. 12/21/2019)
Product: BUP 9MG/ HYDROM 25MG/ SUF 110MCG/ML INJ (20 mL syringe)
Model:
D-0719-2020
Lot Numbers:
12172019@13 (Exp. 12/26/2019)
Product: CJC-1295 2000 mcg/Ipamorelin 2000 mcg/mL Inj. (2 mL vial)
Model:
D-0720-2020
Lot Numbers:
08212019@29 (Exp. 02/17/2020)
07152019@12 (Exp. 01/11/2020)
07082019@26 (Exp. 01/04/2020)
Product: CLON 100MCG/MORP 12MG/ML INJ (20 mL syringe)
Model:
D-0721-2020
Lot Numbers:
12122019@24 (Exp. 12/21/2019)
Product: CLON 300MCG/MORP 10MG/ML INJ (20 mL syringe)
Model:
D-0722-2020
Lot Numbers:
12132019@8 (Exp. 12/22/2019)
Product: CLON 500MCG/HYDROM 5MG/ML INJ (20 mL syringe)
Model:
D-0723-2020
Lot Numbers:
12162019@22 (Exp. 12/25/2019)
Product: CLON 750MCG/MORP 30MG/SUF 37.5MCG/ML (20 mL syringe)
Model:
D-0724-2020
Lot Numbers:
12162019@21 (Exp. 12/25/2019)
Product: CLON 800MCG/FENT 2000MCG/ML INJ (20 mL syringe)
Model:
D-0725-2020
Lot Numbers:
12122019@15 (Exp. 12/21/2019)
Product: FENT 600MCG/ SUF 800MCG/ML INJ (20 mL syringe)
Model:
D-0726-2020
Lot Numbers:
12162019@8 (Exp. 12/25/2019)
Product: FENT 900MCG/SUF 210MCG/ML INJ (20 mL syringe)
Model:
D-0727-2020
Lot Numbers:
12122019@3 (Exp. 12/21/2019)
Product: FENTANYL 3000MCG/ML INJ (20 mL syringe)
Model:
D-0728-2020
Lot Numbers:
12122019@18 (Exp. 12/21/2019)
12162019@24 (Exp. 12/25/2019)
Product: FENTANYL 1000MCG/ML INJ (20 mL syringe)
Model:
D-0729-2020
Lot Numbers:
12182019@3 (Exp. 12/27/2019)
Product: FENTANYL 100MCG/ML INJ (20 mL syringe)
Model:
D-0730-2020
Lot Numbers:
12162019@11 (Exp. 12/25/2019)
Product: FENTANYL 2000MCG/ML INJ (20 mL syringe)
Model:
D-0731-2020
Lot Numbers:
12122019@30 (Exp. 12/21/2019)
Product: FENTANYL 5MG/ML INJ (20 mL syringe)
Model:
D-0732-2020
Lot Numbers:
12122019@14 (Exp. 12/21/2019)
Product: FENTANYL 800MCG/ML INJ (20 mL syringe)
Model:
D-0733-2020
Lot Numbers:
12132019@1 (Exp. 12/22/2019)
Product: HCG 1,000U/1ML INJ (4 mL vial)
Model:
D-0734-2020
Lot Numbers:
11252019@27 (Exp. 12/29/2019)
11272019@30 (Exp. 12/31/2019)
12112019@16 (Exp. 01/14/2020)
12062019@7 (Exp. 01/09/2020)
Product: HCG 10,000U/1ML INJ (4 mL vial)
Model:
D-0735-2020
Lot Numbers:
12162019@38 (Exp. 01/16/2020)
11272019@32 (Exp. 12/31/2019)
Product: HCG 3000U/1ML INJ (4 mL vial)
Model:
D-0736-2020
Lot Numbers:
11272019@31 (Exp. 12/31/2019)
12022019@19 (Exp. 01/05/2020)
Product: HYDROM 10MG/SUF 200MCG/ML INJ (20 mL syringe)
Model:
D-0737-2020
Lot Numbers:
12112019@4 (Exp. 12/20/2019)
Product: HYDROM 17MG/PRIALT 5MCG/ML INJ (20 mL syringe)
Model:
D-0738-2020
Lot Numbers:
12112019@12 (Exp. 12/20/2019)
Product: HYDROM 1MG/MORP 20MG/SUF 100MCG/ML INJ (20 mL syringe)
Model:
D-0739-2020
Lot Numbers:
12162019@3 (Exp. 12/25/2019)
Product: HYDROMORPHONE 15MG/ML INJ (20 mL syringe)
Model:
D-0740-2020
Lot Numbers:
12162019@7 (Exp. 12/25/2019)
Product: HYDROMORPHONE 1MG/ML INJ (20 mL syringe)
Model:
D-0741-2020
Lot Numbers:
12122019@9 (Exp. 12/21/2019)
Product: HYDROMORPHONE 20MG/ML INJ (20 mL syringe)
Model:
D-0742-2020
Lot Numbers:
12122019@17 (Exp. 12/21/2019)
Product: HYDROMORPHONE 2MG/ML INJ (20 mL syringe)
Model:
D-0743-2020
Lot Numbers:
12112019@1 (Exp. 12/20/2019)
12112019@6 (Exp. 12/20/2019)
12162019@23 (Exp. 12/25/2019)
12172019@7 (Exp. 12/26/2019)
Product: HYDROMORPHONE 3MG/ML INJ (20 mL syringe)
Model:
D-0744-2020
Lot Numbers:
12162019@14 (Exp. 12/25/2019)
12102019@19 (Exp. 12/19/2019)
Product: HYDROMORPHONE 4MG/ML INJ (20 mL syringe)
Model:
D-0745-2020
Lot Numbers:
12182019@6 (Exp. 12/27/2019)
Product: HYDROMORPHONE 5MG/ML INJ (20 mL syringe)
Model:
D-0746-2020
Lot Numbers:
12132019@4 (Exp. 12/22/2019)
Product: HYDROMORPHONE 6MG/ML INJ (20 mL syringe)
Model:
D-0747-2020
Lot Numbers:
12132019@9 (Exp. 12/22/2019)
Product: IPAMORELIN 2000MCG/ML INJ (2 mL vial)
Model:
D-0748-2020
Lot Numbers:
07162019@20 (Exp. 01/12/2020)
12102019@17 (Exp. 06/07/2020)
Product: LIPO B (10ML VIAL)
Model:
D-0749-2020
Lot Numbers:
09172019@18 (Exp. 03/15/2020)
Product: MORP 20MG/SUF 70MCG/ML INJ (20 mL syringe)
Model:
D-0750-2020
Lot Numbers:
12112019@9 (Exp. 12/20/2019)
Product: MORPHINE 10MG/ML INJ (20 mL syringe)
Model:
D-0751-2020
Lot Numbers:
12122019@13 (Exp. 12/21/2019)
12172019@9 (Exp. 12/26/2019)
12122019@10 (Exp. 12/21/2019)
12162019@13 (Exp. 12/25/2019)
Product: MORPHINE 15MG/ML INJ (20 mL syringe)
Model:
D-0752-2020
Lot Numbers:
12112019@19 (Exp. 12/20/2019)
Product: MORPHINE 18MG/ML INJ (20 mL syringe)
Model:
D-0753-2020
Lot Numbers:
12162019@30 (Exp. 12/25/2019)
Product: MORPHINE 1MG/ML INJ (20 mL syringe)
Model:
D-0754-2020
Lot Numbers:
12122019@31 (Exp. 12/21/2019)
12172019@8 (Exp. 12/26/2019)
Product: MORPHINE 20MG/ML INJ (20 mL syringe)
Model:
D-0755-2020
Lot Numbers:
12102019@7 (Exp. 12/19/2019)
12112019@11 (Exp. 12/20/2019)
12162019@5 (Exp. 12/25/2019)
Product: MORPHINE 2MG/ML INJ (20 mL syringe)
Model:
D-0756-2020
Lot Numbers:
12162019@20 (Exp. 12/25/2019)
Product: MORPHINE 30MG/ML INJ (20 mL syringe)
Model:
D-0757-2020
Lot Numbers:
12132019@6 (Exp. 12/22/2019)
12182019@5 (Exp. 12/27/2019)
Product: MORPHINE 4MG/ML INJ (20 mL syringe)
Model:
D-0758-2020
Lot Numbers:
12112019@24 (Exp. 12/20/2019)
12122019@1 (Exp. 12/21/2019)
12122019@2 (Exp. 12/21/2019)
Product: MORPHINE 5MG/ML INJ (20 mL syringe)
Model:
D-0759-2020
Lot Numbers:
12122019@7 (Exp. 12/21/2019)
12162019@27 (Exp. 12/25/2019)
Product: MORPHINE 6MG/ML INJ (20 mL syringe)
Model:
D-0760-2020
Lot Numbers:
12162019@19 (Exp. 12/25/2019)
Product: MORPHINE 7MG/ML INJ (20 mL syringe)
Model:
D-0761-2020
Lot Numbers:
12112019@21 (Exp. 12/20/2019)
Product: PHENOL 2.5% STERILE SOLUTION (50 mL syringe)
Model:
D-0762-2020
Lot Numbers:
10142019@14 (Exp. 01/12/2020)
11042019@8 (Exp. 02/02/2020)
Product: QUADMIX (1 mL vial)
Model:
D-0763-2020
Lot Numbers:
07012019@30 (Exp. 12/28/2019)
Product: QUADMIX 30MG/2MG/20MCG/100MCG/ML INJ (1 mL vial)
Model:
D-0764-2020
Lot Numbers:
07012019@30 (Exp. 12/28/2019)
08052019@13 (Exp. 02/01/2020)
09252019@15 (Exp. 03/23/2020)
10292019@12 (Exp. 04/26/2020)
10092019@6 (Exp. 03/04/2020)
10162019@12 (Exp. 04/13/2020)
12042019@31 (Exp. 01/18/2020)
12162019@35 (Exp. 01/30/2020)
11262019@37 (Exp. 05/24/2020)
Product: QUADMIX FORTE (1 mL vial)
Model:
D-0765-2020
Lot Numbers:
08132019@15 (Exp. 02/09/2020)
Product: QUADMIX FORTE 30MG/4MG/40MCG/400MCG/ML INJ (1 mL vial)
Model:
D-0766-2020
Lot Numbers:
07222019@10 (Exp. 01/18/2020)
06242019@19 (Exp. 12/21/2019)
08132019@15 (Exp. 02/09/2020)
10292019@22 (Exp. 04/26/2020)
11272019@24 (Exp. 01/22/2020)
09182019@18 (Exp. 03/16/2020)
Product: SUFENTANIL 150MCG/ML INJ (20 mL syringe)
Model:
D-0767-2020
Lot Numbers:
12162019@26 (Exp. 12/25/2019)
Product: SUFENTANIL 300MCG/ML INJ (20 mL syringe)
Model:
D-0768-2020
Lot Numbers:
12162019@9 (Exp. 12/25/2019)
Product: SUFENTANIL 55.5 MCG/ML IN 18ML INJ (18 mL syringe)
Model:
D-0769-2020
Lot Numbers:
12122019@19 (Exp. 12/21/2019)
Product: TESTOSTERONE CYP 200MG/ML OIL (10 mL vial)
Model:
D-0770-2020
Lot Numbers:
10242019@7 (Exp. 04/21/2020)
10032019@11 (Exp. 03/31/2020)
11042019@12 (Exp. 05/02/2020)
09242019@9 (Exp. 03/22/2020)
Product: TESTOSTERONE CYP 200MG/ML OIL (SESAME) INJ (10 mL vial)
Model:
D-0771-2020
Lot Numbers:
08212019@17 (Exp. 02/17/2020)
10232019@23 (Exp. 04/20/2020)
Product: TESTOSTERONE CYP 200MG/ML OIL INJ (10 mL vial)
Model:
D-0772-2020
Lot Numbers:
09122019@9 (Exp. 03/10/2020)
09242019@9 (Exp. 03/22/2020)
09192019@20 (Exp. 03/17/2020)
10032019@8 (Exp. 03/31/2020)
10032019@11 (Exp. 03/31/2020)
10182019@5 (Exp. 04/15/2020)
10242019@7 (Exp. 04/21/2020)
10232019@24 (Exp. 04/20/2020)
11042019@12 (Exp. 05/02/2020)
11212019@3 (Exp. 05/19/2020)
11212019@2 (Exp. 05/19/2020)
11042019@15 (Exp. 05/02/2020)
Product: TRIMIX 30MG/1MG/10MCG/ML INJ (5 mL/10 mL vial)
Model:
D-0773-2020
Lot Numbers:
07082019@29 (Exp. 01/04/2020)
06252019@11 (Exp. 12/22/2019)
07262019@3 (Exp. 01/22/2020)
07102019@13 (Exp. 01/06/2020)
07162019@13 (Exp. 01/12/2020)
07242019@15 (Exp. 01/20/2020)
08272019@11 (Exp. 02/23/2020)
10012019@19 (Exp. 03/30/2020)
09162019@15 (Exp. 03/14/2020)
09242019@15 (Exp. 03/22/2020)
10162019@16 (Exp. 04/13/2020)
12032019@12 (Exp. 01/17/2020)
Product: TRIMIX (UA) 30MG/1MG/20MCG/ML INJ (1 mL vial)
Model:
D-0774-2020
Lot Numbers:
11042019@28 (Exp. 05/02/2020)
Product: TRIMIX -A (UA) 30MG/1MG/5 MCG/ML INJ (1 mL vial)
Model:
D-0775-2020
Lot Numbers:
07082019@31 (Exp. 01/04/2020)
Product: TRIMIX FORTE 30MG/2MG/20MCG/ML INJ (1 mL vial)
Model:
D-0776-2020
Lot Numbers:
08082019@7 (Exp. 02/04/2020)
08232019@1 (Exp. 02/19/2020)
07262019@12 (Exp. 01/22/2020)
07012019@25 (Exp. 12/28/2019)
07102019@14 (Exp. 01/06/2020)
09202019@4 (Exp. 03/18/2020)
10282019@23 (Exp. 04/25/2020)
10092019@7 (Exp. 03/04/2020)
12042019@20 (Exp. 01/18/2020)
12162019@36 (Exp. 01/30/2020)
Product: TRIMIX FORTE 4 (UA) 30MG/3MG/30MCG/ML INJ (1 mL vial)
Model:
D-0777-2020
Lot Numbers:
08302019@4 (Exp. 02/26/2020)
Product: TRIMIX FORTE PLUS 30MG/4MG/40MCG/ML INJ (1 mL vial)
Model:
D-0778-2020
Lot Numbers:
07032019@12 (Exp. 12/30/2019)
08212019@32 (Exp. 02/17/2020)
10032019@12 (Exp. 03/31/2020)
Product: TRIMIX SUPER (A) 30MG/2MG/30MCG/ML INJ (1 mL vial)
Model:
D-0779-2020
Lot Numbers:
10152019@23 (Exp. 03/04/2020)
10302019@27 (Exp. 04/27/2020)
08052019@19 (Exp. 02/01/2020)
10032019@14 (Exp. 03/31/2020)

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 84546
Status: Resolved
Manufacturer: Assurance Infusion
Sold By: Assurance Infusion
Manufactured In: United States
Units Affected: 118 products (60 vials; 32 droppers; 1 syringe; 1 syringe; 1 syringe; 1 syringe; 1 syringe; 1 syringe; 1 syringe; 1 syringe; 1 syringe; 1 syringe; 1 syringe; 1 syringe; 2 syringes; 15 vials; 5 vials; 28 vials; 1 syringe; 1 syringe; 1 syringe; 2 syringes; 1 syringe; 2 syringes; 1 syringe; 1 syringe; 1 syringe; 2 syringe; 1 syringe; 1 syringe; 1 syringe; 1 syringe; 1 syringe; 1 syringe; 1 syringe; 1 syringe; 1 syringe; 1 syringe; 1 syringe; 1 syringe; 2 syringes; 1 syringe; 1 syringe; 1 syringe; 1 syringe; 1 syringe; 1 syringe; 1 syringe; 1 syringe; 1 syringe; 2 syringes; 1 syringe; 1 syringe; 1 syringe; 1 syringe; 1 syringe; 1 syringe; 1 syringe; 19 vials; 1 syringe; 1 syringe; 1 syringe; 1 syringe; 1 syringe; 1 syringe; 1 syringe; 2 syringe; 1 syringe; 1 syringe; 1 syringe; 1 syringe; 1 syringe; 5 vials; 2 vials; 2 vials; 1 syringe; 1 syringe; 1 syringe; 1 syringe; 1 syringe; 1 syringe; 4 syringes; 2 syringes; 1 syringe; 1 syringe; 1 syringe; 5 vials; 2 syringes/1 vial; 1 syringe; 4 syringes; 1 syringe; 1 syringe; 1 syringe; 3 syringes; 1 syringe; 2 syringes; 3 syringes; 2 syringes; 1 syringe; 1 syringe; 2 syringes; 5 vials; 190 vials; 5 vials; 134 vials; 1 syringe; 1 syringe; 1 syringe; 5 vials; 7 vials; 166 vials; 1290 vials; 1 vial; 10 vials; 358 vials; 10 vials; 20 vials; 45 vials)
Distributed To: Nationwide

Were You Affected by This Recall?

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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.