FDA Recall
Terminated
Historical recordClass II
Trokendi XR (topiramate) extended-release capsule, 50mg, 30-count blister pack, Rx only, Manufactured by: Catalent Pharma Solutions, Winchester, KY 40391, Manufactured for: Supernus Pharmaceuticals, Inc., Rockville, MD 20850, NDC 17772-102-15
by Supernus Pharmaceuticals, Inc.
- Reason
- Superpotent Drug: Failure of assay specifications in the capsule.
- Published
- October 26, 2016
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
PARICALCITOL Capsules, 4 mcg, 30-count bottles, Rx only, Manufactured By: Pharmaceutics International, Inc., Hunt Vallet, MD 21031; Manufactured For: Teva Pharmaceuticals USA, Inc., North Wales, PA 19454, NDC 0093-7658-56.
by Teva Pharmaceuticals USA
- Reason
- Failed Impurities/Degradation Specifications: out of specification test results for impurities during stability testing.
- Published
- October 26, 2016
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
PARICALCITOL Capsules, 2 mcg, 30-count bottles, Rx only, Manufactured By: Pharmaceutics International, Inc., Hunt Vallet, MD 21031; Manufactured For: Teva Pharmaceuticals USA, Inc., North Wales, PA 19454, NDC 0093-7657-56.
by Teva Pharmaceuticals USA
- Reason
- Failed Impurities/Degradation Specifications: out of specification test results for impurities during stability testing.
- Published
- October 26, 2016
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
PARICALCITOL Capsules, 1 mcg, 30-count bottles, Rx only, Manufactured By: Pharmaceutics International, Inc., Hunt Vallet, MD 21031; Manufactured For: Teva Pharmaceuticals USA, Inc., North Wales, PA 19454, NDC 0093-7656-56.
by Teva Pharmaceuticals USA
- Reason
- Failed Impurities/Degradation Specifications: out of specification test results for impurities during stability testing.
- Published
- October 26, 2016
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass III
National Foods Packaging Inc
- Product
- National Foods Packaging Low Sodium Chicken Base in 50 lb wh…
- Reason
- Product contains a spice which was tested and found to contain elevated levels of lead.
- Published
- October 26, 2016
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass III
National Foods Packaging Inc
- Product
- National Foods Packaging Chicken Base in 25 lb white poly-li…
- Reason
- Product contains a spice which was tested and found to contain elevated levels of lead.
- Published
- October 26, 2016
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass III
National Foods Packaging Inc
- Product
- Hillcrest Farms Poultry Gravy Mix in 25lb brown poly-lined b…
- Reason
- Product contains a spice which was tested and found to contain elevated levels of lead.
- Published
- October 26, 2016
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Dollar General Corporation
- Product
- Cookies Bergen, Soft Baked Chocolate Brownie Cookies, NET WE…
- Reason
- Mold found in cookie product
- Published
- October 26, 2016
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
BIMBO Bakeries USA Inc.
- Product
- Entenmann's Little Bites Fudge Brownies - 20 muffins, 5 Pouc…
- Reason
- Presence of plastic in muffins and brownies.
- Published
- October 26, 2016
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
BIMBO Bakeries USA Inc.
- Product
- Entenmann's Little Bites Variety - 20 pouches labeled for re…
- Reason
- Presence of plastic in muffins and brownies.
- Published
- October 26, 2016
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
BIMBO Bakeries USA Inc.
- Product
- Entenmann's Little Bites Chocolate Chip Muffins; 10 Pouches;…
- Reason
- Presence of plastic in muffins and brownies.
- Published
- October 26, 2016
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
morphine Sulfate, 1 mg per mL (5 mg per 5 mL), in 0.9% Sodium Chloride, Preservative Free (Contains Sulfites), 5 mL Total Volume in a syringe, For IV use, Rx only, PharMEDium, Product code 2R3181.
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
methadone HCl, 1 mg per mL, in 0.9% Sodium Chloride, 1 mL Total Volume in a syringe, For IV Use Only, Rx only, PharMEDium, Product code 2T6120.
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
fentaNYL Citrate, 5 mcg per mL (10 mcg per 2 mL) in 0.9% Sodium chloride, 2 mL Total Volume in a syringe, For IV Use, Rx only, PharMEDium, Product code 2R3339.
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
fentaNYL Citrate Injection, 50 mcg per mL (100 mcg per 2 mL), 2 mL Total Volume in a syringe, For IV Use, Rx only, PharMEDium, Product code 2R3303.
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
ePHEDrine Sulfate, 10 mg per mL, in 0.9% Sodium Chloride, Preservative Free, 1 mL Total Volume in a syringe, For IV Use, Rx only, PharMEDium, Product code 2R3347.
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
atropine Sulfate Injection, 0.4 mg per mL, 1 mg per 2.5 mL, 2.5 mL Total Volume in a syringe, For IV use, Rx only, PharMEDium, Product code 2R3324.
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
Amikacin Sulfate Injection, USP, 1 gm/4 mL (250 mg/mL) Rx Only, Manufactured in Hungary For: Teva Pharmaceuticals USA, Inc., North Wales, PA 19454, NDC 0703-9040-01 (individual pack), NDC 0703-9040-03 (shelf-pack carton of 10 vials).
by Teva Pharmaceuticals USA
- Reason
- CGMP Deviations
- Published
- October 19, 2016
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
TAZORAC (tazarotene) Gel 0.05%, Rx only, packaged in 15 x 3.5 g professional sample containers, Manufactured by: Allergan Inc., Irvine, CA 92512. UPC: 300238335159.
by Allergan Sales, LLC
- Reason
- Failed Content Uniformity Specifications
- Published
- October 19, 2016
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
TAZORAC (tazarotene) Gel 0.05%, Rx only, For Dermatologic Use Only, Not for Ophthalmic Use, packaged in a) 30 g tubes (NDC: 0023-8335-03, UPC: 300238335036) and b)100 g tubes,(NDC: 0023-8335-10, UPC: 300238335104), Manufactured by: Allergan Inc., Irvine, CA 92512.
by Allergan Sales, LLC
- Reason
- Failed Content Uniformity Specifications
- 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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