FDA Recall
Terminated
Historical recordClass III
PREMARIN (conjugated estrogen tablets, USP) 1.25 mg, 1000- count bottle, Rx only, Distributed by: Wyeth Pharmaceuticals Inc. A subsidiary of Pfizer Inc. Philadelphia, PA 19101, NDC 0046-1104-91
by Pfizer Inc.
- Reason
- Labeling: Incorrect or Missing Lot and/or Exp Date: Bottles were incorrectly labeled with an expiry date of 11/17; the correct date is 09/17.
- Published
- October 5, 2016
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Senna Syrup (sennosides) 8.8 mg, 8 fl. oz. (237 mL) bottle, Distributed by: Major Pharmaceuticals, 31778 Enterprise Drive, Livonia, MI 48150, NDC 0904-6289-09.
by Pharmatech LLC
- Reason
- CGMP Deviations: Recall initiated as a precautionary measure due to a potential risk of product contamination with the bacteria B. cepacia.
- Published
- October 5, 2016
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Senexon Liquid (sennosides) 8.8 mg, 8 fl oz. (237 mL) bottle, Distributed by: Rugby Laboratories, 31778 Enterprise Drive, Livonia, MI 48150, NDC 0536-1000-59.
by Pharmatech LLC
- Reason
- CGMP Deviations: Recall initiated as a precautionary measure due to a potential risk of product contamination with the bacteria B. cepacia.
- Published
- October 5, 2016
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Diocto Syrup (docusate sodium), 60 mg/15 mL, One Pint (473 mL) bottle, Dist. by: Rugby Laboratories, 31778 Enterprise Drive, Livonia, MI 48150, NDC 0536-1001-85.
by Pharmatech LLC
- Reason
- CGMP Deviations: Recall initiated as a precautionary measure due to a potential risk of product contamination with the bacteria B. cepacia.
- Published
- October 5, 2016
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Aller-Chlor (chlorpheniramine maleate) Syrup, USP, 2 mg in each 5 mL, 4 fl oz (120 mL) bottle, Distributed by: Rugby Laboratories, 31778 Enterprise Drive, Livonia, MI 48150, NDC 0536-1025-47.
by Pharmatech LLC
- Reason
- CGMP Deviations: Recall initiated as a precautionary measure due to a potential risk of product contamination with the bacteria B. cepacia.
- Published
- October 5, 2016
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Ninjacof-A (acetaminophen, chlophedianol HCl, pyrilamine maleate) Liquid, 160 mg/12.5 mg/12.5 mg in each 5 mL, 16 fl oz (473 mL) bottle, Manufactured for: Centurion Labs, LLC, Birmingham, AL 35243, NDC 23359-033-16.
by Pharmatech LLC
- Reason
- CGMP Deviations: Recall initiated as a precautionary measure due to a potential risk of product contamination with the bacteria B. cepacia.
- Published
- October 5, 2016
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Ninjacof (chlophedianol HCl and pyrilamine maleate) Liquid, 12.5 mg/12.5 mg in each 5 mL, 16 fl oz (473 mL) bottle, Manufactured for: Centurion Labs, LLC, Birmingham, AL 35243, NDC 23359-032-16.
by Pharmatech LLC
- Reason
- CGMP Deviations: Recall initiated as a precautionary measure due to a potential risk of product contamination with the bacteria B. cepacia.
- Published
- October 5, 2016
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Sennazon (sennosides) Syrup, 8.8 mg, 8 fl. oz. (237 mL) bottle, Mfd. for: Bayshore Pharmaceuticals, Tampla, FL 33619, NDC 76518-100-08.
by Pharmatech LLC
- Reason
- CGMP Deviations: Recall initiated as a precautionary measure due to a potential risk of product contamination with the bacteria B. cepacia.
- Published
- October 5, 2016
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
Lamotrigine Tablets, USP, 150 mg, 500-count Tablets per bottle, Rx only, Manufactured by: Unichem Laboratories LTD., Pilerne Ind. Estate, Pilerne, Bardez, Goa 403 511 India; Marketed by: Unichem Pharmaceuticals (USA), Inc ., Rochelle Park, NJ 07662; NDC 29300-113-05.
by UNICHEM PHARMACEUTICALS USA INC
- Reason
- Tablets/Capsules Imprinted With Wrong ID: incorrect imprint debossed on the tablets.
- Published
- October 5, 2016
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
Bounce Life Style HQ
- Product
- Bounce Energy Ball Cashew & Pecan Vitality Lift, each loose…
- Reason
- Bounce Energy Ball Cashew & Pecan Vitality Lift is recalled because it has the potential to be contaminated with Listeria monocytogenes. This product contains sunflower kernels that were recalled by supplier SunOpta.
- Published
- October 5, 2016
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
Bounce Life Style HQ
- Product
- Australia -Cashew Cinnamon - Caf¿ Bounce, each bulk bag cont…
- Reason
- Cashew Cinnamon - Caf¿ Bounce is recalled because it has the potential to be contaminated with Listeria monocytogenes. This product contains sunflower kernels that were recalled by supplier SunOpta.
- Published
- October 5, 2016
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
Bounce Life Style HQ
- Product
- US - Bounce Apple Cinnamon Protein Punch Energy Balls (old n…
- Reason
- Apple Cinnamon Protein Punch Energy Ball product is recalled because it has the potential to be contaminated with Listeria monocytogenes. This product contains sunflower kernels that were recalled by supplier SunOpta.
- Published
- October 5, 2016
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
Mozobil (plerixafor injection) 24 mg/1.2 mL (20 mg/mL) per vial, Rx Only, For Subcutaneous Injection only, Manufactured by: Genzyme Corporation, 500 Kendall Street, Cambridge, MA 02142 A Sanofi Company Country of Origin : United Kingdom, NDC 0024-5862-01
by Genzyme Corporation / Genzyme Biosurgery
- Reason
- Labeling: Incorrect or Missing Lot and/or Exp. Date
- Published
- September 28, 2016
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
Escitalopram Tablets USP 20 mg, 100-count bottles, Rx Only, Manufactured for: Lupin Pharmaceuticals, Baltimore, MD, 21202, Manufactured by: Lupin Limited, Goa 403 722, India, NDC 68180-136-01
by Lupin Limited
- Reason
- Labeling: Incorrect or Missing Lot and/or Expiration Date
- Published
- September 28, 2016
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
Amoxicillin For Oral Suspension, USP - Dye Free, 400 mg/5 mL, 100 mL (when reconstituted), Rx only, Manufactured by: Hikma Pharmaceuticals, PO Box 182400, Amman 11118 - Jordan, Distributed by: West-Ward Pharmaceutical Corp. Eatontown, NJ 07724, NDC 00143-9887-01,
by West-Ward Pharmaceuticals Corp.
- Reason
- Labeling: Label Error on Declared Strength- bottles missing colored coded panel where strength of the product is displayed.
- Published
- September 28, 2016
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Phenylephrine HCI Injection, USP, 10mg/mL, packaged in a) 5 mL Vial, 50 mg/5 mL (NDC 66758-016-03), 25 x 5 mL Vials per carton (NDC 66758-016-04) and b) 10 mL Vials, 100 mg/10 mL (NDC 66758-017-01), Rx only, Manufactured for: Sandoz Inc., Princeton, NJ 08540.
by Sandoz Inc
- Reason
- Lack of Assurance of Sterility: a recent FDA inspection at the manufacturing firm raised concerns that product sterility may be compromised.
- Published
- September 28, 2016
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Ephedrine Sulfate Injection, USP, 50 mg/mL, 1 mL Fill in a 2mL Vial (NDC 66758-008-01), packaged in 25 x 2 mL Vials per carton (NDC 66758-008-02), Rx only, Manufactured for: Sandoz Inc., Princeton, NJ 08540.
by Sandoz Inc
- Reason
- Lack of Assurance of Sterility: a recent FDA inspection at the manufacturing firm raised concerns that product sterility may be compromised.
- Published
- September 28, 2016
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
Carvediol Tablets, USP, 25 mg, 100-count bottle (NDC 57664-247-88), 500-count bottle (NDC 57664-247-13), 1000-count bottle (NDC 57664-247-18), Rx Only Manufactured by: ALKALOIDA Chemical Company Zrt 440 Tisavasvari Kabay Janos u. 29 Hungary, Distributed by: Sun Pharmaceutical Industries, Inc. Cranbury, NJ 08512
by Sun Pharmaceutical Industries, Inc.
- Reason
- Failed Impurities/Degradation Specifications
- Published
- September 28, 2016
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
Carvediol Tablets, USP, 12.5 mg, 500-count bottle (NDC 57664-245-13), 1000-count bottle (NDC 57664-245-18), Rx Only Manufactured by: ALKALOIDA Chemical Company Zrt 440 Tisavasvari Kabay Janos u. 29 Hungary, Distributed by Sun Pharmaceutical Industries, Inc. Cranbury, NJ 08512
by Sun Pharmaceutical Industries, Inc.
- Reason
- Failed Impurities/Degradation Specifications
- Published
- September 28, 2016
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
Carvediol Tablets, USP, 6.25 mg, 100-count bottle (NDC 57664-244-18), 500-count bottle (NDC 57664-244-13), 1000-count bottle (NDC 57664-244-18), Rx Only, Manufactured by: ALKALOIDA Chemical Company Zrt 440 Tisavasvari Kabay Janos u. 29 Hungary, Distributed by Sun Pharmaceutical Industries, Inc. Cranbury, NJ 08512
by Sun Pharmaceutical Industries, Inc.
- Reason
- Failed Impurities/Degradation Specifications
- Published
- September 28, 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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