FDA Recall
Terminated
Historical recordClass II
Magnesium Hydroxide 2400 mg, Aluminum Hydroxide 2400 mg, Simethicone 240 mg MAX, per 30 mL Oral Suspension, 30 mL cup, packaged in 10 cups per tray, 10 trays per carton, For Institutional Use Only, Major Pharmaceuticals, 17177 N Laurel Park Dr., Suite 233, Livonia, MI 48152, NDC 0904-6839-73
by Plastikon Healthcare LLC
- Reason
- CGMP Deviations: products manufactured under conditions which reflect manufacturing processes that were not adequately controlled.
- Published
- September 14, 2022
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Magnesium Hydroxide 1200 mg, Aluminum Hydroxide 1200 mg, Simethicone 120 mg per 30 mL, 30 mL cup, packaged in 10 cups per tray, 10 trays per carton, For Institutional Use Only, Major Pharmaceuticals, 17177 N Laurel Park Dr., Suite 233, Livonia, MI 48152, NDC 0904-6838-73
by Plastikon Healthcare LLC
- Reason
- CGMP Deviations: products manufactured under conditions which reflect manufacturing processes that were not adequately controlled.
- Published
- September 14, 2022
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
MILK OF MAGNESIA USP, 2400 mg/10 mL, Magnesium Hydroxide, 30 mL cup, packaged in 10 cups per tray, 10 trays per carton, For Institutional Use Only, Major Pharmaceuticals, 17177 N Laurel Park Dr., Suite 233, Livonia, MI 48152, NDC 0904-6840-72.
by Plastikon Healthcare LLC
- Reason
- CGMP Deviations: products manufactured under conditions which reflect manufacturing processes that were not adequately controlled.
- Published
- September 14, 2022
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
MILK OF MAGNESIA USP, 2400 mg/30 mL, Magnesium Hydroxide, 30 mL cup, packaged in 10 cups per tray, 10 trays per carton, For Institutional Use Only, Major Pharmaceuticals, 17177 N Laurel Park Dr., Suite 233, Livonia, MI 48152, NDC 0904-6846-73.
by Plastikon Healthcare LLC
- Reason
- CGMP Deviations: products manufactured under conditions which reflect manufacturing processes that were not adequately controlled.
- Published
- September 14, 2022
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass I
Magnesium Hydroxide 2400 mg, Aluminum Hydroxide 2400 mg, Simethicone 240 mg MAX, per 30 mL Oral Suspension, 30 mL cup, packaged in 10 cups per tray, 10 trays per carton, For Institutional Use Only, Major Pharmaceuticals, 17177 N Laurel Park Dr., Suite 233, Livonia, MI 48152, NDC 0904-6839-73
by Plastikon Healthcare LLC
- Reason
- Microbial Contamination of Non-Sterile Products.
- Published
- September 14, 2022
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass I
Magnesium Hydroxide 1200 mg, Aluminum Hydroxide 1200 mg, Simethicone 120 mg per 30 mL, 30 mL cup, packaged in 10 cups per tray, 10 trays per carton, For Institutional Use Only, Major Pharmaceuticals, 17177 N Laurel Park Dr., Suite 233, Livonia, MI 48152, NDC 0904-6838-73
by Plastikon Healthcare LLC
- Reason
- Microbial Contamination of Non-Sterile Products.
- Published
- September 14, 2022
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass I
MILK OF MAGNESIA USP, 2400 mg/10 mL, Magnesium Hydroxide, 30 mL cup, packaged in 10 cups per tray, 10 trays per carton, For Institutional Use Only, Major Pharmaceuticals, 17177 N Laurel Park Dr., Suite 233, Livonia, MI 48152, NDC 0904-6840-72.
by Plastikon Healthcare LLC
- Reason
- Microbial Contamination of Non-Sterile Products.
- Published
- September 14, 2022
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass I
MILK OF MAGNESIA USP, 2400 mg/30 mL, Magnesium Hydroxide, 30 mL cup, packaged in 10 cups per tray, 10 trays per carton, For Institutional Use Only, Major Pharmaceuticals, 17177 N Laurel Park Dr., Suite 233, Livonia, MI 48152, NDC 0904-6846-73.
by Plastikon Healthcare LLC
- Reason
- Microbial Contamination of Non-Sterile Products
- Published
- September 14, 2022
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Piantedosi Baking Co., Inc.
- Product
- Gourmet Potato Slider Rolls 24-pack (033474512045)
- Reason
- Products may be contaminated with Cronobacter sakazakii and/or Clostridium botulinum
- Published
- September 14, 2022
- Distribution
- Multiple states
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Piantedosi Baking Co., Inc.
- Product
- Brioche-Style Slider Roll 24-pack (033474512021)
- Reason
- Products may be contaminated with Cronobacter sakazakii and/or Clostridium botulinum
- Published
- September 14, 2022
- Distribution
- Multiple states
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Piantedosi Baking Co., Inc.
- Product
- Gourmet Potato Deli Roll 12-pack (033474509526)
- Reason
- Products may be contaminated with Cronobacter sakazakii and/or Clostridium botulinum
- Published
- September 14, 2022
- Distribution
- Multiple states
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Piantedosi Baking Co., Inc.
- Product
- Slider Rolls No Seeds 24-pack (033474504941)
- Reason
- Products may be contaminated with Cronobacter sakazakii and/or Clostridium botulinum
- Published
- September 14, 2022
- Distribution
- Multiple states
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Piantedosi Baking Co., Inc.
- Product
- B & W Gourmet Burger Roll 12-pack (033474504644)
- Reason
- Products may be contaminated with Cronobacter sakazakii and/or Clostridium botulinum
- Published
- September 14, 2022
- Distribution
- Multiple states
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Piantedosi Baking Co., Inc.
- Product
- Sunset Burger Roll 12-pack (033474504187)
- Reason
- Products may be contaminated with Cronobacter sakazakii and/or Clostridium botulinum
- Published
- September 14, 2022
- Distribution
- Multiple states
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Piantedosi Baking Co., Inc.
- Product
- Brioche Style Burger Roll 12-pack (033474504170)
- Reason
- Products may be contaminated with Cronobacter sakazakii and/or Clostridium botulinum
- Published
- September 14, 2022
- Distribution
- Multiple states
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Piantedosi Baking Co., Inc.
- Product
- Split Top Burger Roll 12-pack (033474503777)
- Reason
- Products may be contaminated with Cronobacter sakazakii and/or Clostridium botulinum
- Published
- September 14, 2022
- Distribution
- Multiple states
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Piantedosi Baking Co., Inc.
- Product
- Gourmet Potato Deli Roll 12-pack (033474503647)
- Reason
- Products may be contaminated with Cronobacter sakazakii and/or Clostridium botulinum
- Published
- September 14, 2022
- Distribution
- Multiple states
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Piantedosi Baking Co., Inc.
- Product
- Hawaiian Sandwich Roll 12-pack (033474502978)
- Reason
- Products may be contaminated with Cronobacter sakazakii and/or Clostridium botulinum
- Published
- September 14, 2022
- Distribution
- Multiple states
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Piantedosi Baking Co., Inc.
- Product
- B & W Sweet Burger Roll 12-pack (033474502947)
- Reason
- Products may be contaminated with Cronobacter sakazakii and/or Clostridium botulinum
- Published
- September 14, 2022
- Distribution
- Multiple states
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Piantedosi Baking Co., Inc.
- Product
- Clustered Potato Burger Roll 12-pack (033474502855)
- Reason
- Products may be contaminated with Cronobacter sakazakii and/or Clostridium botulinum
- Published
- September 14, 2022
- Distribution
- Multiple states
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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