FDA Recall
TerminatedTerminated: June 9, 2021Historical recordClass I
Ketorolac Tromethamine Injection, USP 30 mg/mL, packaged in 1 mL Single Dose Vials (NDC 0641-6042-01), 25 vials/shelf-pack (NDC 0641-6042-25), For IV or IM Use Only, Rx only, Manufactured by: WEST-WARD Eatontown, NJ 07724 USA.
by Hikma Pharmaceuticals USA Inc.
- Reason
- Presence of Particulate Matter: particles identified as polydimethylsiloxane (PDMS)
- Published
- January 22, 2020
- Distribution
- Nationwide
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FDA Recall
TerminatedTerminated: November 20, 2023Historical recordClass II
Lipoic Acid Injection (aka Alpha Lipoic Acid or Thioctic Acid), 1,200 mg/30 mL (40 mg/mL) Sterile 30 mL Multiple Dose Vial, Rx Only, McGuff Compounding Pharmacy Services, Inc., Santa Ana, CA 92704
by McGuff Compounding Pharmacy Services, Inc.
- Reason
- Presence of Particulate Matter: filmy/cloudy particulate observed in vial.
- Published
- January 22, 2020
- Distribution
- Nationwide
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FDA Recall
TerminatedTerminated: June 3, 2021Historical recordClass III
Tri-Lo-Marzia (Norgestimate and Ethinyl Estradiol Tablets, USP), 0.180 mg/0.025 mg; 0.215mg/0.025 mg and 0.250 mg/0.025 mg, Pack size - 3 x 28's wallets/carton, Rx Only, Distributed by Lupin Pharmaceuticals, Inc, Baltimore MD 21202, Manufactured by: Lupin Limited, Pithampur, (M.P.)- 454775, India. NDC 68180-837-13 (3x28 carton ) NDC 68180-837-11 (28 tablet wallet)
by Lupin Pharmaceuticals Inc.
- Reason
- CGMP Deviations: Out of specification test result observed during retrospective review of blend uniformity test data.
- Published
- January 22, 2020
- Distribution
- Nationwide
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FDA Recall
TerminatedTerminated: November 22, 2022Historical recordClass III
Moxifloxacin Ophthalmic Solution USP, 0.5%, Sterile, 3mL Bottle, Rx Only, For Topical Ophthalmic Use Only, Distributed by: Aurobindo Pharma USA, Inc., East Windsor, NJ 08520, Made in India, NDC 65862-840-03.
by AuroMedics Pharma LLC
- Reason
- Discoloration: Market complaints of discoloration in Moxifloxacin Ophthalmic Solution.
- Published
- January 22, 2020
- Distribution
- Nationwide
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FDA Recall
TerminatedTerminated: October 27, 2021Historical recordClass II
TRIMIX SUPER (A) 30MG/2MG/30MCG/ML INJ in 1 mL vial Assurance Infusion (713) 533-8800
by Assurance Infusion
- Reason
- Lack of sterility assurance.
- Published
- January 22, 2020
- Distribution
- Nationwide
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FDA Recall
TerminatedTerminated: October 27, 2021Historical recordClass II
TRIMIX FORTE PLUS 30MG/4MG/40MCG/ML INJ in 1 mL vial Assurance Infusion (713) 533-8800
by Assurance Infusion
- Reason
- Lack of sterility assurance.
- Published
- January 22, 2020
- Distribution
- Nationwide
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FDA Recall
TerminatedTerminated: October 27, 2021Historical recordClass II
TRIMIX FORTE 30MG/2MG/20MCG/ML INJ in 1 mL vial Assurance Infusion (713) 533-8800
by Assurance Infusion
- Reason
- Lack of sterility assurance.
- Published
- January 22, 2020
- Distribution
- Nationwide
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FDA Recall
TerminatedTerminated: October 27, 2021Historical recordClass II
TRIMIX -A (UA) 30MG/1MG/5 MCG/ML INJ in 1 mL vial Assurance Infusion (713) 533-8800
by Assurance Infusion
- Reason
- Lack of sterility assurance.
- Published
- January 22, 2020
- Distribution
- Nationwide
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FDA Recall
TerminatedTerminated: October 27, 2021Historical recordClass II
TRIMIX (UA) 30MG/1MG/20MCG/ML INJ in 1 mL vial Assurance Infusion (713) 533-8800
by Assurance Infusion
- Reason
- Lack of sterility assurance.
- Published
- January 22, 2020
- Distribution
- Nationwide
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FDA Recall
TerminatedTerminated: October 27, 2021Historical recordClass II
TRIMIX 30MG/1MG/10MCG/ML INJ in 5 mL/10 mL vials Assurance Infusion (713) 533-8800
by Assurance Infusion
- Reason
- Lack of sterility assurance.
- Published
- January 22, 2020
- Distribution
- Nationwide
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FDA Recall
TerminatedTerminated: October 27, 2021Historical recordClass II
TESTOSTERONE CYP 200MG/ML OIL INJ in 10 mL vial Assurance Infusion (713) 533-8800
by Assurance Infusion
- Reason
- Lack of sterility assurance.
- Published
- January 22, 2020
- Distribution
- Nationwide
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FDA Recall
TerminatedTerminated: October 27, 2021Historical recordClass II
TESTOSTERONE CYP 200MG/ML OIL (SESAME) INJ in 10 mL vial Assurance Infusion (713) 533-8800
by Assurance Infusion
- Reason
- Lack of sterility assurance.
- Published
- January 22, 2020
- Distribution
- Nationwide
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FDA Recall
TerminatedTerminated: October 27, 2021Historical recordClass II
SUFENTANIL 55.5 MCG/ML IN 18ML INJ in 18 mL syringe Assurance Infusion (713) 533-8800
by Assurance Infusion
- Reason
- Lack of sterility assurance.
- Published
- January 22, 2020
- Distribution
- Nationwide
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FDA Recall
TerminatedTerminated: October 27, 2021Historical recordClass II
SUFENTANIL 300MCG/ML INJ in 20 mL syringe Assurance Infusion (713)-533-8800
by Assurance Infusion
- Reason
- Lack of sterility assurance.
- Published
- January 22, 2020
- Distribution
- Nationwide
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FDA Recall
TerminatedTerminated: October 27, 2021Historical recordClass II
SUFENTANIL 150MCG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800
by Assurance Infusion
- Reason
- Lack of sterility assurance.
- Published
- January 22, 2020
- Distribution
- Nationwide
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FDA Recall
TerminatedTerminated: October 27, 2021Historical recordClass II
QUADMIX FORTE in 1 mL vial Assurance Infusion (713) 533-8800
by Assurance Infusion
- Reason
- Lack of sterility assurance.
- Published
- January 22, 2020
- Distribution
- Nationwide
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FDA Recall
TerminatedTerminated: October 27, 2021Historical recordClass II
QUADMIX 30MG/2MG/20MCG/100MCG/ML INJ in 1 mL vial Assurance Infusion (713) 533-8800
by Assurance Infusion
- Reason
- Lack of sterility assurance.
- Published
- January 22, 2020
- Distribution
- Nationwide
View recall →
FDA Recall
TerminatedTerminated: October 27, 2021Historical recordClass II
QUADMIX in 1 mL vial Assurance Infusion (713)-533-8800
by Assurance Infusion
- Reason
- Lack of sterility assurance.
- Published
- January 22, 2020
- Distribution
- Nationwide
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FDA Recall
TerminatedTerminated: October 27, 2021Historical recordClass II
PHENOL 2.5% STERILE SOLUTION in 50 mL syringe Assurance Infusion (713) 533-8800
by Assurance Infusion
- Reason
- Lack of sterility assurance.
- Published
- January 22, 2020
- Distribution
- Nationwide
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FDA Recall
TerminatedTerminated: October 27, 2021Historical recordClass II
MORPHINE 7MG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800
by Assurance Infusion
- Reason
- Lack of sterility assurance.
- Published
- January 22, 2020
- Distribution
- Nationwide
View recall →
Recall records are summarized from official FDA and USDA sources. Notices may be updated, reclassified, terminated, or withdrawn. Always review the linked official notice for the most current instructions.
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