FDA Recall
TerminatedTerminated: June 23, 2017Historical recordClass II
fentaNYL Citrate, 5 mcg per mL, 15 mcg per 3mL, in 0.9% Sodium chloride, 3 mL Total Volume in a syringe, For IV Use, Rx only, PharMEDium, Product code 2R3318.
by PharMEDium Services, LLC
- Reason
- Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes.
- Published
- October 19, 2016
- Distribution
- Nationwide
View recall →
FDA Recall
TerminatedTerminated: June 23, 2017Historical recordClass II
fentaNYL Citrate Injection, 50 mcg per mL, 250 mcg per 5 mL, 5mL Total Volume in a syringe, For IV Use, Rx only, PharMEDium, Product code 2R3306.
by PharMEDium Services, LLC
- Reason
- Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes.
- Published
- October 19, 2016
- Distribution
- Nationwide
View recall →
FDA Recall
TerminatedTerminated: June 23, 2017Historical recordClass II
fentaNYL Citrate, 25 mcg per mL in 0.9% Sodium chloride, 1 mL Total Volume in a syringe, For IV Use, Rx only, PharMEDium, Product code 2R3236.
by PharMEDium Services, LLC
- Reason
- Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes.
- Published
- October 19, 2016
- Distribution
- Nationwide
View recall →
FDA Recall
TerminatedTerminated: June 23, 2017Historical recordClass II
fentaNYL Citrate, 10 mcg per 1 mL, in 0.9% Sodium Chloride, Preservative Free, 1 mL Total Volume in a syringe, For IV Use, Rx only, PharMEDium, Product code 2R3174.
by PharMEDium Services, LLC
- Reason
- Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes.
- Published
- October 19, 2016
- Distribution
- Nationwide
View recall →
FDA Recall
TerminatedTerminated: June 23, 2017Historical recordClass II
fentaNYL Citrate Injection, 50 mcg per mL, Preservative Free, 1 mL Total Volume in a syringe, For IV Use, Rx only, PharMEDium, Product code 2R3153.
by PharMEDium Services, LLC
- Reason
- Subpotent Drug and Stability Data Does Not Support Expiry: confirmed subpotency and potential loss of potency in drugs packaged and stored in syringes.
- Published
- October 19, 2016
- Distribution
- Nationwide
View recall →
FDA Recall
TerminatedTerminated: June 23, 2017Historical recordClass II
fentaNYL Citrate Injection, 50 mcg per mL, Preservative Free, 1 mL Total Volume in a syringe, For IV Use, Product code 2R3118, NDC 61553-118-40
by PharMEDium Services, LLC
- Reason
- Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes.
- Published
- October 19, 2016
- Distribution
- Nationwide
View recall →
FDA Recall
TerminatedTerminated: June 23, 2017Historical recordClass II
Fentanyl Citrate 16.67 mcg per mL and Bupivacaine HCl 0.1667% in 0.9% Sodium Chloride, Total Dose 25.005 mcg/1.5 mL Fentanyl Citrate, Content Volume 1.5 mL in 3 mL BD Syringe, Intended for Epidural Use, Rx only, PharMEDium, Product code 2T6228.
by PharMEDium Services, LLC
- Reason
- Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes.
- Published
- October 19, 2016
- Distribution
- Nationwide
View recall →
FDA Recall
TerminatedTerminated: June 23, 2017Historical recordClass II
ePHEDrine Sulfate, 10 mg per mL, 50 mg per 5 mL, in 0.9% Sodium Chloride, Preservative Free, 5 mL Total Volume in a syringe, For IV Use, Rx only, PharMEDium, Product code 2R3308.
by PharMEDium Services, LLC
- Reason
- Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes.
- Published
- October 19, 2016
- Distribution
- Nationwide
View recall →
FDA Recall
TerminatedTerminated: June 23, 2017Historical recordClass II
ePHEDrine Sulfate, 5 mg per mL, 25 mg per 5 mL, in 0.9% Sodium Chloride, Preservative Free, 5 mL Total Volume in a syringe, For IV Use, Rx only, PharMEDium, Product code 2R3301.
by PharMEDium Services, LLC
- Reason
- Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes.
- Published
- October 19, 2016
- Distribution
- Nationwide
View recall →
FDA Recall
TerminatedTerminated: June 23, 2017Historical recordClass II
Buffered Lidocaine, 2%, In Sodium Bicarbonate 8.4%, 3 mL Total Volume in a syringe, Local anesthetic use, Rx only, PharMEDium, Product code 2K2475.
by PharMEDium Services, LLC
- Reason
- Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes.
- Published
- October 19, 2016
- Distribution
- Nationwide
View recall →
FDA Recall
TerminatedTerminated: June 23, 2017Historical recordClass II
Buffered Lidocaine, 1%, In Sodium Bicarbonate 8.4%, 1 mL Total Volume in a syringe, Local anesthetic use, Rx only, PharMEDium, Product code 2K2466.
by PharMEDium Services, LLC
- Reason
- Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes.
- Published
- October 19, 2016
- Distribution
- Nationwide
View recall →
FDA Recall
TerminatedTerminated: June 23, 2017Historical recordClass II
atropine Sulfate Injection, 0.4 mg per mL, 0.8 mg per 2 mL, 2 mL Total Volume in a syringe, For IV Use, Rx only, PharMEDium, Product code 2R3335.
by PharMEDium Services, LLC
- Reason
- Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes.
- Published
- October 19, 2016
- Distribution
- Nationwide
View recall →
FDA Recall
TerminatedTerminated: February 5, 2018Historical recordClass II
Amikacin Sulfate Injection, USP, 500 mg/2 mL (250 mg/mL) Rx Only, Manufactured in Hungary For: Teva Pharmaceuticals USA, Inc., North Wales, PA 19454, NDC 0703-9032-01 (individual pack), NDC 0703-9032-03 (shelf-pack carton of 10 vials).
by Teva Pharmaceuticals USA
- Reason
- CGMP Deviations
- Published
- October 19, 2016
- Distribution
- Nationwide
View recall →
FDA Recall
TerminatedTerminated: March 27, 2017Historical recordClass I
Diocto Liquid (docusate sodium) 50 mg/5 mL Stool Softener Laxative, One Pint (473 mL) bottles, Dist by: Rugby Laboratories, Livonia, MI --- NDC 0536-0590-85
by The Harvard Drug Group
- Reason
- Microbial contamination of Non-Sterile Products; positive findings of Burkholderia cepacia
- Published
- October 19, 2016
- Distribution
- Nationwide
View recall →
FDA Recall
TerminatedTerminated: May 3, 2017Historical recordClass II
Vancomycin 10 mg/mL in 0.9% Sodium Chloride (Injection) 1 mL Total Volume in a 2 mL Vial (Preservative Free), Compounded by Leiter's Compounding, San Jose, CA --- NDC 70360-005-35
by Leiter's Compounding
- Reason
- Lack of Assurance of Sterility; all compounded products within expiry produced using recalled filters
- Published
- October 19, 2016
- Distribution
- Nationwide
View recall →
FDA Recall
TerminatedTerminated: May 3, 2017Historical recordClass II
Placebo for Prednisolone Acetate 1%, Oph Suspension, 10 mL Dropper Bottle, Compounded by Leiter's Compounding, San Jose, CA
by Leiter's Compounding
- Reason
- Lack of Assurance of Sterility; all compounded products within expiry produced using recalled filters
- Published
- October 19, 2016
- Distribution
- Nationwide
View recall →
FDA Recall
TerminatedTerminated: May 3, 2017Historical recordClass II
Moxifloxacin 1 mg/mL in Sterile Balanced Salt Solution (BSS) Intravitreal Injection, 1 mL Total Volume in a 2 mL Vial, Compounded by Leiter's Compounding, San Jose, CA --- NDC 70360-003-35
by Leiter's Compounding
- Reason
- Lack of Assurance of Sterility; all compounded products within expiry produced using recalled filters
- Published
- October 19, 2016
- Distribution
- Nationwide
View recall →
FDA Recall
TerminatedTerminated: May 3, 2017Historical recordClass II
Mitomycin 0.02% (0.2 mg/mL) in Sterile Water for Injection (Injection) 1 mL Total Volume in a 2 mL Vial (Preservative Free), Compounded by Leiter's Compounding, San Jose, CA --- NDC 70360-005-35
by Leiter's Compounding
- Reason
- Lack of Assurance of Sterility; all compounded products within expiry produced using recalled filters
- Published
- October 19, 2016
- Distribution
- Nationwide
View recall →
FDA Recall
TerminatedTerminated: May 3, 2017Historical recordClass II
Lidocaine HCl 1% - Phenylephrine HCl 1.5% in Sterile Water for Injection (Injection) 1 mL Total Volume in a 2 mL Vial (Preservative Free), Compounded by Leiter's Compounding, San Jose, CA --- NDC 70360-002-35
by Leiter's Compounding
- Reason
- Lack of Assurance of Sterility; all compounded products within expiry produced using recalled filters
- Published
- October 19, 2016
- Distribution
- Nationwide
View recall →
FDA Recall
TerminatedTerminated: May 3, 2017Historical recordClass II
Cyclopentolate HCl 1% - Tropicamide 1% - PHENYLephrine HCl 2.5% in Sterile Water for Injection (Ophthalmic Solution), in a) 1 mL Total Volume (NDC 70360-017-38) and b) 10 mL Total Volume (NDC 70360-017-39) in a 15 mL Dropper Bottle, Compounded by Leiter's Compounding, San Jose, CA --- NDC 70360-017-38
by Leiter's Compounding
- Reason
- Lack of Assurance of Sterility; all compounded products within expiry produced using recalled filters
- Published
- October 19, 2016
- 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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