FDA Recall
Terminated
Historical recordClass III
ZENATANE (isotretinoin capsules USP) 20 mg, 30 capsules per prescription pack, Rx Only, Manufactured by: Cipla Limited, Kurkumbh Village Pune 4138012 India, Manufactured for: Dr. Reddy's Laboratories Limited Bachupally 500 090 India, NDC 55111-136-81
by Dr. Reddy's Laboratories, Inc.
- Reason
- Failed Dissolution Specifications
- Published
- October 19, 2016
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Marcaine 0.5% (bupivacaine HCl) injection, USP, 250 mg/50 mL (5 mg/mL), 50 mL Multiple-Dose Vial, Rx only, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-1610-50.
by Hospira Inc., A Pfizer Company
- Reason
- Lack of Assurance of Sterility and Subpotent Drug: defect in glass vial prevented stopper from forming a seal allowing water to ingress and dilute the product causing it to be less than the labeled potency.
- Published
- October 19, 2016
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Marcaine 0.25% (bupivacaine HCl) injection, USP, 125 mg/50 mL (2.5 mg/mL), 50 mL Multiple-Dose Vial, Rx only, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-1587-50.
by Hospira Inc., A Pfizer Company
- Reason
- Lack of Assurance of Sterility and Subpotent Drug: defect in glass vial prevented stopper from forming a seal allowing water to ingress and dilute the product causing it to be less than the labeled potency.
- Published
- October 19, 2016
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
mitoXANTRONE Injection USP (concentrate), 20 mg/10 mL (2 mg/mL), 10 mL Multiple Dose Vial, Rx only, Teva Parenteral Medicines, Inc., Irvine, CA 92618, NDC 0703-4685-01.
by Teva Pharmaceuticals USA
- Reason
- Failed Impurities/Degradation Specifications: potential failure to meet the specification for Impurity D throughout shelf-life.
- Published
- October 19, 2016
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass I
5% Dextrose Injection USP, 100mL in a 150 mL PAB container, Rx only, B. Braun Medical Inc. Irvine, CA 92614-5895 USA, NDC 00264-1510-32
by B. Braun Medical Inc
- Reason
- Non-Sterility: fungal contamination due to leaking containers.
- Published
- October 19, 2016
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass I
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
- Subpotent Drug: confirmed subpotency in one lot of this product that was packaged and stored in syringes.
- Published
- October 19, 2016
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
lidocaine HCl, 2%, 20 mg per mL (100 mg per 5 mL), 5 mL Total Volume in a syringe, Rx only, PharMEDium, Product code 2R3110.
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
Terminated
Historical recordClass II
lidocaine HCl, 1%, in 0.9% Sodium Chloride, Preservative Free, Total Volume 3 mL in a syringe, Rx only, PharMEDium, Product code 2R3343.
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
Terminated
Historical recordClass II
succinylcholine Chloride Injection, 20 mg per mL, 100 mg per 5 mL, 5 mL Total Volume in a syringe, For IV Use, Rx only, PharMEDium, Product code 2R3357.
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
Terminated
Historical recordClass II
rocuronium Bromide, 10 mg per mL, 50 mg per 5 mL, Preservative Free, 5 mL Total Volume in a syringe, For IV Use, Rx only, PharMEDium, Product code 2R3321.
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
Terminated
Historical recordClass II
remifentanil HCl, 50 mcg per mL, 100 mcg per 2 mL, in 0.9% Sodium Chloride, Preservative Free, 2 mL Total Volume in a syringe, Rx only, PharMEDium, Product code 2R3300.
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
Terminated
Historical recordClass II
PHENYLephrine HCl, 100 mcg per mL, 0.5 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 2R3346.
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
Terminated
Historical recordClass II
PHENYLephrine HCl, 100 mcg per mL, 0.5 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 2R3109.
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
Terminated
Historical recordClass II
PHENYLephrine HCl, 40 mcg per mL, 200 mcg 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 2R3376.
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
Terminated
Historical recordClass II
neostigmine Methylsulfate, 1 mg per mL, 3 mg per 3 mL, 3 mL Total Volume in a syringe, For IV Use, Rx only, PharMEDium, Product code 2R3551.
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
Terminated
Historical recordClass II
neostigmine Methylsulfate, 1 mg per mL, 2 mg per 2 mL, 2 mL Total Volume in a syringe, For IV Use, Rx only, PharMEDium, Product code 2R3550.
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
Terminated
Historical recordClass II
neostigmine Methylsulfate, 1 mg per mL, 5 mg per 5 mL, 5 mL Total Volume in a syringe, For IV Use, Rx only, PharMEDium, Product code 2R3326.
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
Terminated
Historical recordClass II
morphine Sulfate, 2 mg per mL, in 0.9% Sodium Chloride, 1 mL Total Volume in a syringe, For IV Use, Rx only, PharMEDium, Product code 2T6455.
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
Terminated
Historical recordClass II
morphine Sulfate, 1 mg per mL (2 mg per 2 mL), in 0.9% Sodium Chloride, Preservative Free, 2 mL Total Volume in a syringe, For IV Use, Rx only, PharMEDium, Product code 2R3353.
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
Terminated
Historical recordClass II
morphine Sulfate, 1 mg per mL (2 mg per 2 mL), in 0.9% Sodium Chloride, Preservative Free (Contains Sulfites), 2 mL Total Volume in a syringe, For IV use, Rx only, PharMEDium, Product code 2R3259.
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 →
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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