FDA Recall
Terminated
Historical recordClass I
Dexmedetomidine HCl in 0.9% Sodium Chloride Injection, 200 mcg per 50 mL (4 mcg per mL), for intravenous infusion, preservative free, 50 mL Single Dose Bottle, Rx only, Fresenius Kabi Lake Zurich, IL 60047, NDC 63323-671-05
by Fresenius Kabi USA, LLC
- Reason
- Cross Contamination with other products: trace amounts of lidocaine
- Published
- September 2, 2020
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Sulfamethoxazole and Trimethoprim Tablets, USP, 800 mg/160 mg Double Strength, 500 Tablets per bottle, Rx Only, Distributed by: Aurobindo Pharma USA, Inc. 279 Princeton-Hightstown Road, East Windsor, NJ 08520, Made in India, NDC: 65862-420-05.
by Aurobindo Pharma USA Inc.
- Reason
- Presence of Foreign Substance: product complaints were received by the firm for the presence of metal wire in the tablet(s).
- Published
- September 2, 2020
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass I
Chlorhexidine Gluconate 0012 For Manufacturing, Processing or Repacking, RX Only, Medichem, S.A. Poligono Industrial Celra, 17460, Celra, Girona (Spain/Espana); Fructuos Gelabert, 6-8, 08970, Sant Joan Despi, Barcelona (Spain/Espana) NDC 53296-0012-0
by Medichem S.A.
- Reason
- Microbial contamination of Non-Sterile Product; detection of the gram-negative bacillus Serratia marcescens in certain API batches
- Published
- September 2, 2020
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Buprenorphine HCl Injection, 0.3 mg/mL, 1 mL vial, For Intramuscular or Intravenous Use Only, Rx Only, Manufactured by: Hikma Farmaceutica, Portugal S.A., Distributed by: Hikma Pharmaceuticals, Eatontown, NJ 07724, USA Inc., NDC: 0143-9246-01.
by Hikma Pharmaceuticals USA Inc.
- Reason
- Sub-potent Drug: Out-of-Specification assay results found at 3 month stability testing.
- Published
- September 2, 2020
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
Thomson International, Inc.
- Product
- Sweet Yellow onions; Packed under brand names of Thomson Pr…
- Reason
- Traceback investigation into an outbreak of Salmonella Newport illnesses found red onions to be a suspect vehicle for the outbreak. After notification from FDA, firm initiated a recall.
- Published
- September 2, 2020
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
Thomson International, Inc.
- Product
- White onions; Packed under brand names of Thomson Premium,…
- Reason
- Traceback investigation into an outbreak of Salmonella Newport illnesses found red onions to be a suspect vehicle for the outbreak. After notification from FDA, firm initiated a recall.
- Published
- September 2, 2020
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
Thomson International, Inc.
- Product
- Yellow onions; Packed under brand names of Onions 52, Majes…
- Reason
- Traceback investigation into an outbreak of Salmonella Newport illnesses found red onions to be a suspect vehicle for the outbreak. After notification from FDA, firm initiated a recall.
- Published
- September 2, 2020
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
Thomson International, Inc.
- Product
- Red onions; Packed under brand names of Thomson Premium, On…
- Reason
- Traceback investigation into an outbreak of Salmonella Newport illnesses found red onions to be a suspect vehicle for the outbreak. After notification from FDA, firm initiated a recall.
- Published
- September 2, 2020
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Phentermine HCL Blue Speckled tablets, 37.5 mg, packaged in a) 14-count bags (NDC 10702-0025-10) and b) 28-count bags (NDC 10702-0025-10), Rx Only, Distributed by: Calvin Scott & Co., Inc. Albuquerque, NM 87123, MFG: KVK-Tech., Inc Newtown, PA 18940.
by Calvin Scott & Company, Inc.
- Reason
- CGMP Deviations: Light sensitive drug products repackaged in transparent/partially transparent pouches.
- Published
- August 26, 2020
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Phentermine HCL White/Blue Speckled tablets, 37.5 mg, packaged in a) 7-count bags, and b) 28-count bags, Rx only, Distributed by: Calvin Scott & Co., Inc. Albuquerque, NM 87123, Manufactured by Lannett Company, Inc. Philadelphia, PA 19136; NDC 00527-1445-10
by Calvin Scott & Company, Inc.
- Reason
- CGMP Deviations: Light sensitive drug products repackaged in transparent/partially transparent pouches.
- Published
- August 26, 2020
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Phentermine HCL White/Blue Speck Tabs 37.5 mg, 28-count bags, Rx only, Distributed by: Calvin Scott & Co., Inc. Albuquerque, NM 87123 Manufactured by SUN Pharmaceuticals, NDC 53489-0676-10
by Calvin Scott & Company, Inc.
- Reason
- CGMP Deviations: Light sensitive drug products repackaged in transparent/partially transparent pouches.
- Published
- August 26, 2020
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Phentermine HCL Blue/White Capsules, 37.5 mg, 28-count bags, Rx only, Distributed by: Calvin Scott & Co., Inc. Albuquerque, NM 87123, MFG: KVK-Tech., Inc Newtown, PA 18940; NDC 10702-0029-10
by Calvin Scott & Company, Inc.
- Reason
- CGMP Deviations: Light sensitive drug products repackaged in transparent/partially transparent pouches.
- Published
- August 26, 2020
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Phentermine HCL Blue/Clear capsules, 30mg, packaged in a) 10-count bags (NDC 10702-0028-10), b) 28-count bags (NDC 10702-0028-10) and c) 56-count bags (NDC 10702-0028-10), Distributed by: Calvin Scott & Co., Inc. Albuquerque, NM 87123, Manufactured by KVK-Tech Newtown, PA 18940; NDC 10702-0028-10
by Calvin Scott & Company, Inc.
- Reason
- CGMP Deviations: Light sensitive drug products repackaged in transparent/partially transparent pouches.
- Published
- August 26, 2020
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Phentermine HCL Yellow Caps 30mg, packaged in 28-count bags, Rx only, Distributed by: Calvin Scott & Co., Inc. Albuquerque, NM 87123, MFG: Tagi Pharma, South Beloit, IL 61080; NDC 51224-0202-70
by Calvin Scott & Company, Inc.
- Reason
- CGMP Deviations: Light sensitive drug products repackaged in transparent/partially transparent pouches.
- Published
- August 26, 2020
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Phentermine HCL GrayYellow capsules, 15mg, packaged in a) 28-count bags and b) 56-count bags, Rx only, Distributed by: Calvin Scott & Co., Inc. Albuquerque, NM 87123, MFG: Tagi Pharma, South Beloit, IL 61080; NDC 51224-0203-70
by Calvin Scott & Company, Inc.
- Reason
- CGMP Deviations: Light sensitive drug products repackaged in transparent/partially transparent pouches.
- Published
- August 26, 2020
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Phentermine 15mg grey/Yellow Capsules, 28-count bags, Rx only, Distributed by: Calvin Scott & Co., Inc. Albuquerque, NM 87123, MFG: Sunrise Pharm., Rahway NJ, 07065; NDC 11534-0157-03
by Calvin Scott & Company, Inc.
- Reason
- CGMP Deviations: Light sensitive drug products repackaged in transparent/partially transparent pouches.
- Published
- August 26, 2020
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Phentermine HCL Gray/Yellow capsules, 15mg, 28-count bags, Rx only, Distributed by: Calvin Scott & Co., Inc. Albuquerque, NM 87123 Manufactured by Kvk-Tech, NDC 10702-0026-10
by Calvin Scott & Company, Inc.
- Reason
- CGMP Deviations: Light sensitive drug products repackaged in transparent/partially transparent pouches.
- Published
- August 26, 2020
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Phendimetrazine Brown/Clear Capsules, 105 mg, 28-count bags, Rx only, Distributed by: Calvin Scott & Co., Inc. Albuquerque, NM 87123, Manufactured by Virtus Pharm., LLC Newtown, PA 18940; NDC 69543-0409-11
by Calvin Scott & Company, Inc.
- Reason
- CGMP Deviations: Light sensitive drug products repackaged in transparent/partially transparent pouches.
- Published
- August 26, 2020
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Phendimetrazine Yellow Tabs 35mg, packaged in a) 10-count bags (NDC 69543-0410-11) and b) 28-count bags (NDC 69543-0410-11), and c) 56-count bags (NDC 69543-0410-11) Rx only, Distributed by: Calvin Scott & Co., Inc. Albuquerque, NM 87123, Manufactured by Virtus Pharm, LLC.
by Calvin Scott & Company, Inc.
- Reason
- CGMP Deviations: Light sensitive drug products repackaged in transparent/partially transparent pouches.
- Published
- August 26, 2020
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Phendimetrazine Yellow Tabs 35mg, 28-count bags, Rx only, Distributed by: Calvin Scott & Co., Inc. Albuquerque, NM 87123, MFG: KVK-Tech, Newtown, PA 18940, NDC 0702-0077-10
by Calvin Scott & Company, Inc.
- Reason
- CGMP Deviations: Light sensitive drug products repackaged in transparent/partially transparent pouches.
- Published
- August 26, 2020
- 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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