FDA Recall
Terminated
Historical recordClass II
Estradiol 18 mg pellet , 99.5% Estradiol USP, .5% Stearic Acid NF in 1 count, 12 count, and 30 count bottles, Sterile Office Use Only, Subcutaneous Use Only, Rx Only, Manufactured by: Qualgen 14844 Bristol Park Blvd Edmond, OK 73013 NDC: 69761-018-01.
by Qualgen
- Reason
- CGMP deviations- Lack of Quality Assurance
- Published
- June 14, 2017
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Estradiol 20 mg pellet 99.5% Estradiol USP, .5% Stearic Acid NF in 1 count and 12 count bottles, Sterile Office Use Only, For Subcutaneous Use Only Rx Only, Manufactured by Qualgen 14844 Bristol Park Blvd Edmond, OK 73013 NDC: 69761-020-01
by Qualgen
- Reason
- CGMP deviations- Lack of Quality Assurance
- Published
- June 14, 2017
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Estradiol 22 mg pellet 99.5% Estradiol USP, .5% Stearic Acid NF, in 1 count, 12 count, and 30 count bottles, Sterile Office Use Only, For Subcutaneous Use Only Rx Only, Manufactured by: Qualgen 14844 Bristol Park Blvd Edmond, OK 73013 NDC 69761-022-01
by Qualgen
- Reason
- CGMP deviations- Lack of Quality Assurance
- Published
- June 14, 2017
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Estradiol 25 mg pellet 99.5% Estradiol USP, .5% Stearic Acid NF, in 1 count, 12 count, and 30 count bottles, Sterile Office Use Only, For Subcutaneous Use Only. Rx Only ,Manufactured by: Qualgen 14844 Bristol Park Blvd Edmond, OK 73013 NDC 69761-025-01,
by Qualgen
- Reason
- CGMP deviations- Lack of Quality Assurance
- Published
- June 14, 2017
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Option 2, Levonorgestrel Tablet, 1.5 mg, Emergency Contraceptive, 1 Tablet per box, Distributed By Perrigo, Allegan, MI 49010. NDC 0113-2003-12
by L. Perrigo Company
- Reason
- Defective Container: Carton is missing the tablet blister strip and tablet.
- Published
- June 14, 2017
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Zenatane (isotretinoin) Capsules, USP, 40 mg, 30-count (3 x 10 Prescription Packs) per carton, Rx Only, Manufactured By: Cipla Limited, Kurkumbh Village, Pune 413802 India, Manufactured For: Dr. Reddy's Laboratories, Bachupally 500 090 India, NDC 55111-137-81
by Dr. Reddy's Laboratories, Inc.
- Reason
- Failed Dissolution Specifications: out of specification results observed for low dissolution.
- Published
- June 14, 2017
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Zenatane (isotretinoin) Capsules, USP, 30 mg, 30-count (3 x 10 Prescription Packs) per carton, Rx Only, Manufactured By: Cipla Limited, Kurkumbh Village, Pune 413802 India, Manufactured For: Dr. Reddy's Laboratories, Bachupally 500 090 India, NDC 55111-113-81
by Dr. Reddy's Laboratories, Inc.
- Reason
- Failed Dissolution Specifications: out of specification results observed for low dissolution.
- Published
- June 14, 2017
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Zenatane (isotretinoin) Capsules, USP, 20 mg, 30-count (3 x 10 Prescription Packs) per carton, Rx Only, Manufactured By: Cipla Limited, Kurkumbh Village, Pune 413802 India, Manufactured For: Dr. Reddy's Laboratories, Bachupally 500 090 India, NDC 55111-136-81
by Dr. Reddy's Laboratories, Inc.
- Reason
- Failed Dissolution Specifications: out of specification results observed for low dissolution.
- Published
- June 14, 2017
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Zenatane (isotretinoin) Capsules, USP, 10 mg, 30-count (3 x 10 Prescription Packs) per carton, Rx Only, Manufactured By: Cipla Limited, Kurkumbh Village, Pune 413802 India, Manufactured For: Dr. Reddy's Laboratories, Bachupally 500 090 India, NDC 55111-135-81
by Dr. Reddy's Laboratories, Inc.
- Reason
- Failed Dissolution Specifications: out of specification results observed for low dissolution.
- Published
- June 14, 2017
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Levonorgestrel, U.S.P. active pharmaceutical ingredient, packaged in 1 kg container, Rx only, Spectrum Chemical Mfg. Corp, Gardena, CA 90248, New Brunswick, NJ 08901, Product code L1229.
by Spectrum Laboratory Products, Inc.
- Reason
- CGMP Deviations: these repackaged and redistributed products are being recalled due to a recall notice from the active pharmaceutical ingredient manufacturer for deviations from current Good Manufacturing Practices that were found during a recent FDA inspection.
- Published
- June 14, 2017
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Estradiol (17-B-Estradiol; Estra-1,3,5(10)-triene-3, 17B-diol; Oestradiol) Plant Base, Micronized, U.S.P active pharmaceutical ingredient, packaged in 1g, 5g, 25g, 6 x 25g, and 100g containers, Rx only, Spectrum Chemical Mfg. Corp, Gardena, CA 90248, New Brunswick, NJ 08901, Product code E1435.
by Spectrum Laboratory Products, Inc.
- Reason
- CGMP Deviations: these repackaged and redistributed products are being recalled due to a recall notice from the active pharmaceutical ingredient manufacturer for deviations from current Good Manufacturing Practices that were found during a recent FDA inspection.
- Published
- June 14, 2017
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Fourth Street Barbeque, Inc.
- Product
- Pick 5 Chicken & Waffle Sandwich; Mix & Match, Keep Frozen;…
- Reason
- Product has the potential to be contaminated with Listeria monocytogenes.
- Published
- June 14, 2017
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Completed
Historical recordClass II
Pinnacle Foods, LLC
- Product
- Mrs. Butter-worth's(R) ORIGINAL PANCAKES, 144 COUNT, NET WT…
- Reason
- Potential for Listeria monocytogenes contamination
- Published
- June 14, 2017
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Completed
Historical recordClass II
Pinnacle Foods, LLC
- Product
- Aunt Jemima(R) Cinnamon Swirl Thick French Toast, 144 COUNT,…
- Reason
- Potential for Listeria monocytogenes contamination
- Published
- June 14, 2017
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Completed
Historical recordClass II
Pinnacle Foods, LLC
- Product
- Hilltop HEARTH WAFFLES, 18 BOLSAS CON 8 PIEZAS, PESO NETO 11…
- Reason
- Potential for Listeria monocytogenes contamination
- Published
- June 14, 2017
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Completed
Historical recordClass II
Pinnacle Foods, LLC
- Product
- Aunt Jemima(R) Whole Grain Mini Pancakes, 12-40 COUNT, NET W…
- Reason
- Potential for Listeria monocytogenes contamination
- Published
- June 14, 2017
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Completed
Historical recordClass II
Pinnacle Foods, LLC
- Product
- Aunt Jemima(R) Cinnamon Swirl French Toast, 144 COUNT, NET W…
- Reason
- Potential for Listeria monocytogenes contamination
- Published
- June 14, 2017
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Completed
Historical recordClass II
Pinnacle Foods, LLC
- Product
- Waffles packaged as follows: a) Aunt Jemima(R) Waffles, 144…
- Reason
- Potential for Listeria monocytogenes contamination
- Published
- June 14, 2017
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Completed
Historical recordClass II
Pinnacle Foods, LLC
- Product
- Aunt Jemima(R) Thick French toast, 72 COUNT, NET WT 10.7 LBS…
- Reason
- Potential for Listeria monocytogenes contamination
- Published
- June 14, 2017
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Completed
Historical recordClass II
Pinnacle Foods, LLC
- Product
- Aunt Jemima(R) Original Thin French toast, 144 COUNT, NET WT…
- Reason
- Potential for Listeria monocytogenes contamination
- Published
- June 14, 2017
- 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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