FDA Recall
CompletedHistorical recordClass II
Camber Pharmaceuticals, Inc. Valsartan Tablets, USP, 320 mg, 90 tablets, Rx Only Manufactured for: Camber Pharmaceuticals, Inc. Piscataway NJ 08854 By: Hetero Hetero Labs Limited Unit V, Pollepally Jadcherla Mahaboob Nagar - 509-301 India. NDC 31722-748-90 UPC 331722748902
by Hetero Labs Limited Unit V
- Reason
- CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
- Published
- August 29, 2018
- Distribution
- Nationwide
View recall →
FDA Recall
CompletedHistorical recordClass II
Camber Pharmaceuticals, Inc. Valsartan Tablets, USP, 160 mg, 90 tablets Rx Only Manufactured for: Camber Pharmaceuticals, Inc. Piscataway NJ 08854 By: Hetero Hetero Labs Limited, Unit V, Pollepally Jadcherla Mahabubnagar - 509-301, India. NDC 31722-747-90 UPC 331722747905
by Hetero Labs Limited Unit V
- Reason
- CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
- Published
- August 29, 2018
- Distribution
- Nationwide
View recall →
FDA Recall
CompletedHistorical recordClass II
Camber Pharmaceuticals, Inc. Valsartan Tablets, USP, 80 mg, 90 count bottles, Rx Only Manufactured for: Camber Pharmaceuticals, Inc. Piscataway NJ 08854 By: Hetero Hetero Labs Limited Unit V. Polepally Jadcherla Mahaboob Nagar - 509-301 India. NDC 31722-746-90 UPC 331722746908
by Hetero Labs Limited Unit V
- Reason
- CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
- Published
- August 29, 2018
- Distribution
- Nationwide
View recall →
FDA Recall
CompletedHistorical recordClass II
Camber Pharmaceuticals, Inc. Valsartan Tablets, USP, 40 mg, 30 Tablets Rx Only Manufactured for: Camber Pharmaceuticals, Inc. Piscataway NJ 08854 By: Hetero Hetero Labs Limited Unit V, Polepally Jadcherla Mahaboob Nagar - 509-301, India. NDC 31722-745-30 UPC 331722745307
by Hetero Labs Limited Unit V
- Reason
- CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
- Published
- August 29, 2018
- Distribution
- Nationwide
View recall →
FDA Recall
TerminatedTerminated: June 26, 2020Historical recordClass III
Diltiazem HCl Extended-release Capsules, USP 120 mg, 80 capsules, 8 blister cards of 10 capsules each per carton, Rx Only, Manufactured by: Mylan Pharmaceuticals Inc., Morgantown, WV. NDC 51079-947-08
by Mylan Institutional, Inc. (d.b.a. UDL Laboratories)
- Reason
- Failed Impurities/Degradation Specifications; out of specification results for related compound per the manufacturer
- Published
- August 29, 2018
- Distribution
- Nationwide
View recall →
FDA Recall
OngoingHistorical recordClass II
Valsartan and Hydrochlorothiazide Tablets, Valsartan 320 MG and Hydrochlorothiazide 25 MG, 90 tablets per bottle, Rx Only, MFG: Arrow Pharm (Malta) LTD, Birzebbugia, BBG 3000 Malta. NDC: 54569-6488-0
by A-S Medication Solutions LLC.
- Reason
- CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
- Published
- August 29, 2018
- Distribution
- Nationwide
View recall →
FDA Recall
OngoingHistorical recordClass II
Valsartan and Hydrochlorothiazide Tablets, Valsartan 160 MG and Hydrochlorothiazide 12.5 MG, 90 tablets per bottle, Rx Only, MFG: Arrow Pharm (Malta) LTD, Birzebbugia, BBG 3000 Malta. NDC: 54569-6480-0
by A-S Medication Solutions LLC.
- Reason
- CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
- Published
- August 29, 2018
- Distribution
- Nationwide
View recall →
FDA Recall
OngoingHistorical recordClass II
Valsartan Tablets, 80 MG, 30-count bottle (NDC 54569-6582-0, 90-count bottle (NDC 54569-6582-1), Rx Only, MFG: Zhejiang Huahai Pharma, Linhai, Zhejiang 317024 China
by A-S Medication Solutions LLC.
- Reason
- CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
- Published
- August 29, 2018
- Distribution
- Nationwide
View recall →
FDA Recall
OngoingHistorical recordClass II
Valsartan Tablets, 160 MG, 30-count bottle (NDC 54569-6583-0), 90-count bottle (NDC 54569-6583-1), Rx Only, MFG: Zhejiang Huahai Pharma, Linhai, Zhejiang 317024 China
by A-S Medication Solutions LLC.
- Reason
- CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
- Published
- August 29, 2018
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
TerminatedTerminated: September 27, 2018Historical recordClass II
Banks Square Market Corp dba The Produce Connection
- Product
- Zuchini and summer squash mixed noodles packaged under the f…
- Reason
- Product may be contaminated with Listeria monocytogenes.
- Published
- August 29, 2018
- Distribution
- Product was directly distributed to the…
View recall →
FDA Recall
🇺🇸 United States
TerminatedTerminated: September 27, 2018Historical recordClass II
Banks Square Market Corp dba The Produce Connection
- Product
- Zuchini noodles packaged under the following brands - the PI…
- Reason
- Product may be contaminated with Listeria monocytogenes.
- Published
- August 29, 2018
- Distribution
- Product was directly distributed to the…
View recall →
FDA Recall
🇺🇸 United States
TerminatedTerminated: September 27, 2018Historical recordClass II
Banks Square Market Corp dba The Produce Connection
- Product
- Summer squash noodles packaged under the following brands -…
- Reason
- Product may be contaminated with Listeria monocytogenes.
- Published
- August 29, 2018
- Distribution
- Product was directly distributed to the…
View recall →
FDA Recall
🇺🇸 United States
TerminatedTerminated: October 11, 2018Historical recordClass I
Country Favor Inc.
- Product
- BEST TASTE BRAND SNACK GINGER SLICED, Net Weight 200g, 7 OZ,…
- Reason
- Product contains high levels of undeclared sulfites.
- Published
- August 29, 2018
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
TerminatedTerminated: February 8, 2019Historical recordClass I
SALT & STRAW LLC
- Product
- Chocolate Gooey Brownie Ice Cream, packaged in pint-sized co…
- Reason
- Chocolate Gooey Brownie Ice Cream is recalled due to possible undeclared peanuts.
- Published
- August 29, 2018
- Distribution
- Distributed in CA, OR, and WA. Firm a…
View recall →
FDA Recall
🇺🇸 United States
TerminatedTerminated: September 19, 2018Historical recordClass II
J R Simplot Co Corporate HQ
- Product
- Simplot Good Grains Exotic Grains & Fire-Roasted Vegetable B…
- Reason
- Simplot Good Grains Exotic Grains & Fire-Roasted Vegetable Blend is recalled due to undeclared wheat.
- Published
- August 29, 2018
- Distribution
- distributed in CA, CO, CT, FL, GA, KS, M…
View recall →
FDA Recall
🇺🇸 United States
TerminatedTerminated: February 8, 2019Historical recordClass I
Gift Services Inc Warehouse
- Product
- Sherman Candy Caramels are individually wrapped in plastic a…
- Reason
- Sherman Candy Caramels product is recalled due to undeclared pecans, walnuts, almonds and/or peanuts.
- Published
- August 29, 2018
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
TerminatedTerminated: March 4, 2019Historical recordClass II
Graeters Manufacturing Company
- Product
- Graeter's HANDCRAFTED French Pot ICE CREAM, Limited Edition…
- Reason
- Product is labeled as gluten free, however, it contains wheat.
- Published
- August 29, 2018
- Distribution
- Products were distributed in the followi…
View recall →
FDA Recall
🇺🇸 United States
TerminatedTerminated: March 20, 2019Historical recordClass II
Natures Bounty Inc
- Product
- BLUE GREEN ALGAE: Packaged under the following brands: AMERI…
- Reason
- High level of microcystin observed in the product.
- Published
- August 29, 2018
- Distribution
- Nationwide
View recall →
FDA Recall
TerminatedTerminated: November 15, 2019Historical recordClass III
Contrave (naltrexone HCl and bupropion HCl) Extended-Release Tablets, 8 mg/90 mg, 120-count bottle, Rx only, Distributed by Orexigen therapeutics, Inc., La Jolla, CA 92037, NDC 51267-890-99.
by Orexigen Therapeutics, Inc.
- Reason
- Defective Container: Customer complaints of punctures in the bottle.
- Published
- August 22, 2018
- Distribution
- Nationwide
View recall →
FDA Recall
TerminatedTerminated: April 15, 2020Historical recordClass III
Atorvastatin Calcium tablets, 40 mg, 500-count bottle, Rx only, Mfd By: Dr. Reddy's Laboratories Limited, Srikakulam - 532 409 India, NDC 55111-123-05
by Dr. Reddy's Laboratories, Inc.
- Reason
- Failed Impurities/Degradation Specifications - OOS was observed for ATV Cyclo FP Impurity and Total Degradation Impurities tested at the 18 month stability time point in Atorvastatin Calcium Tablets 40 mg 500 tablets.
- Published
- August 22, 2018
- 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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