FDA Recall
Terminated
Historical recordClass II
Metformin Hydrochloride Extended-Release Tablets USP, 750 mg 100 Tablets Rx Only Manufactured by: Beximco Pharmaceuticals, LTD. 126, Kathaldia, Tongi, Gazipur, 1711, Bangladesh NDC 76385-129-01
by BAYSHORE PHARMACEUTICALS
- Reason
- CGMP Deviations
- Published
- September 2, 2020
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Metformin Hydrochloride Extended-Release Tablets USP, 500 mg 1000 Tablets Rx Only Manufactured by: Beximco Pharmaceuticals, LTD. 126, Kathaldia, Tongi, Gazipur, 1711, Bangladesh NDC 76385-128-10
by BAYSHORE PHARMACEUTICALS
- Reason
- CGMP Deviations
- Published
- September 2, 2020
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
Red Cross Oral Pain (Oral Anesthetic benzocaine 20%), Maximum Strength, 1/8 Fl. Oz. (3.7 mL) bottle with Cotton Pellets box packaged in a blister pack, Distributed by: Mentholatum Company, Orchard Park, NY 14127 NDC 10742-8902-1, UPC 3 10742 09509 8
by The Mentholatum Company
- Reason
- Labeling; Not Elsewhere Classified: The Mentholatum Company is initiating a voluntary recall due to an error in the labeling of the cotton pellet box found within the Red Cross Oral Pain blister pack. The cotton pellet box states that the product contains "Natural Eugenol Oil" in which it does not.
- Published
- September 2, 2020
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Hand Sanitizer (Alcohol 80% v/v) topical solution, 55 US GAL (208 L) EcoLab Inc 1 EcoLab Place St. Paul, MN 55102 USA, NDC 47593-624-21
by Ecolab Inc
- Reason
- Discoloration and Presence of Foreign Substance
- Published
- September 2, 2020
- Distribution
- Nationwide
View recall →
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
🇺🇸 United States
Terminated
Historical recordClass I
Emerald Fruit & Produce Inc
- Product
- Onions Yellow Whole Dry 5 lb. bag (item 78155) for foodservi…
- Reason
- Processed onions products are recalled due to a potential contamination with Salmonella Newport. Onions were supplied from Thomson International Inc.
- Published
- September 2, 2020
- Distribution
- distributed in OR only.
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
Emerald Fruit & Produce Inc
- Product
- M60058CS Onions White Diced sold by pound for foodservice us…
- Reason
- Processed onions products are recalled due to a potential contamination with Salmonella Newport. Onions were supplied from Thomson International Inc.
- Published
- September 2, 2020
- Distribution
- distributed in OR only.
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
Emerald Fruit & Produce Inc
- Product
- M60064CS Onions White Sliced sold by pound for foodservice u…
- Reason
- Processed onions products are recalled due to a potential contamination with Salmonella Newport. Onions were supplied from Thomson International Inc.
- Published
- September 2, 2020
- Distribution
- distributed in OR only.
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
Emerald Fruit & Produce Inc
- Product
- Onions Red Whole Dry 5 lb. bag (item 78156) for food service…
- Reason
- Processed onions products are recalled due to a potential contamination with Salmonella Newport. Onions were supplied from Thomson International Inc.
- Published
- September 2, 2020
- Distribution
- distributed in OR only.
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
Emerald Fruit & Produce Inc
- Product
- M60022CS Onions Red Diced sold by pound for foodservice use.…
- Reason
- Processed onions products are recalled due to a potential contamination with Salmonella Newport. Onions were supplied from Thomson International Inc.
- Published
- September 2, 2020
- Distribution
- distributed in OR only.
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
Emerald Fruit & Produce Inc
- Product
- M60025CS Onions Yellow Diced sold by pound for foodservice u…
- Reason
- Processed onions products are recalled due to a potential contamination with Salmonella Newport. Onions were supplied from Thomson International Inc.
- Published
- September 2, 2020
- Distribution
- distributed in OR only.
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
Emerald Fruit & Produce Inc
- Product
- Onions Red Rings 3/16 (item 78267) sold by 5 lb bag for food…
- Reason
- Processed onions products are recalled due to a potential contamination with Salmonella Newport. Onions were supplied from Thomson International Inc.
- Published
- September 2, 2020
- Distribution
- distributed in OR only.
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
Emerald Fruit & Produce Inc
- Product
- Onions White Whole Dry 5 lb bag (item 78158) for foodservice…
- Reason
- Processed onions products are recalled due to a potential contamination with Salmonella Newport. Onions were supplied from Thomson International Inc.
- Published
- September 2, 2020
- Distribution
- distributed in OR only.
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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