FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Pepsico Inc
- Product
- Starbucks Doubleshot Espresso, Espresso & Cream, 6.5 FL OZ U…
- Reason
- An issue with adequate sealing of canned coffee products potentially lead to premature spoilage.
- Published
- November 10, 2021
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Kansas City LLC., DBA Best Harvest Bakeries
- Product
- Hotdog buns, in unlabeled clear plastic bags, 30 or 12 buns…
- Reason
- Positive environmental samples analyzed for Listeria and Salmonella species.
- Published
- November 10, 2021
- Distribution
- Distributed to restaurants in AR, CO, IA…
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Kansas City LLC., DBA Best Harvest Bakeries
- Product
- Potato buns, in unlabeled clear plastic bags, 30 or 12 buns…
- Reason
- Positive environmental samples analyzed for Listeria and Salmonella species.
- Published
- November 10, 2021
- Distribution
- Distributed to restaurants in AR, CO, IA…
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Kansas City LLC., DBA Best Harvest Bakeries
- Product
- Hamburger buns, 5" in unlabeled clear plastic bags, 30 or 12…
- Reason
- Positive environmental samples analyzed for Listeria and Salmonella species.
- Published
- November 10, 2021
- Distribution
- Distributed to restaurants in AR, CO, IA…
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Kansas City LLC., DBA Best Harvest Bakeries
- Product
- Hamburger buns, 4.5" in unlabeled clear plastic bags, 30 or…
- Reason
- Positive environmental samples analyzed for Listeria and Salmonella species.
- Published
- November 10, 2021
- Distribution
- Distributed to restaurants in AR, CO, IA…
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Kansas City LLC., DBA Best Harvest Bakeries
- Product
- Hamburger buns, 4" in unlabeled clear plastic bags, 30 or 12…
- Reason
- Positive environmental samples analyzed for Listeria and Salmonella species.
- Published
- November 10, 2021
- Distribution
- Distributed to restaurants in AR, CO, IA…
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Kansas City LLC., DBA Best Harvest Bakeries
- Product
- Hotdog buns, customer specified formula, in unlabeled clear…
- Reason
- Positive environmental samples analyzed for Listeria and Salmonella species.
- Published
- November 10, 2021
- Distribution
- Distributed to restaurants in AR, CO, IA…
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Kansas City LLC., DBA Best Harvest Bakeries
- Product
- Hamburger buns, customer specified formula, in unlabeled cle…
- Reason
- Positive environmental samples analyzed for Listeria and Salmonella species.
- Published
- November 10, 2021
- Distribution
- Distributed to restaurants in AR, CO, IA…
View recall →
FDA Recall
Terminated
Historical recordClass III
Gatifloxacin Ophthalmic Solution, 0.5%, 2.5 mL bottle, Rx only, Manufactured by: Lupin Limited, Pithampur (M.P.) 454 775, INDIA, NDC 68180-435-01.
by Lupin Pharmaceuticals Inc.
- Reason
- Failed Stability Specifications: Out-of-specification results observed in a water loss test that might affect the assay content and alter drug concentration.
- Published
- November 3, 2021
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
Rizatriptan Benzoate Orally Disintegrating Tablets 10mg, 18 Tablets (3 x 6 Unit-Dose Tablets) Blister Packs, Rx only, Manufactured for: Macleods Pharma USA Inc. Plainsboro, NJ 08536, Manufactured by: Macleods Pharmaceuticals Ltd. Baddi, Himachal Pradesh, INDIA, NDC 33342-094-41
by MACLEODS PHARMA USA, INC
- Reason
- Out-of-specification test results obtained in Organic Impurities test during analysis of controlled samples.
- Published
- November 3, 2021
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
Rizatriptan Benzoate Orally Disintegrating Tablets 5mg, 12 Tablets (2 x 6 Unit-Dose Tablets) Blister Packs, Rx only, Manufactured for: Macleods Pharma USA Inc. Plainsboro, NJ 08536, Manufactured by: Macleods Pharmaceuticals Ltd. Baddi, Himachal Pradesh, INDIA, NDC 33342-093-41
by MACLEODS PHARMA USA, INC
- Reason
- Out-of-specification test results obtained in Organic Impurities test during analysis of controlled samples.
- Published
- November 3, 2021
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
Rizatriptan Benzoate Film Coated Tablets, 10 mg, packaged in a) 12 Tablets (2X6 Unit-Dose Tablets) Blister Packs, NDC 33342-088-45), b) 18 Tablets (3 x 6 Unit-Dose Tablets, NDC 33342-088-41) Rx only, Manufactured for: Macleods Pharma USA, Inc. Plainsboro, NJ 08536l Manufactured by: Macleods Pharmaceuticals Ltd. Baddi, Himachal Pradesh, INDIA
by MACLEODS PHARMA USA, INC
- Reason
- Out-of-specification test results obtained in Organic Impurities test during analysis of controlled samples.
- Published
- November 3, 2021
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
Afassco Pain Free Plus X-STRENGTH PAIN RELIEVER (Acetaminophen 250 mg/Aspirin 250 mg/Caffeine 65 mg) tablets, 2 Tablets/package, Packaged in 12,000 Packets/Case, PO# 19540, Mfg. for: Afassco Minden, NV 89423 (Shipping Label)
by Ultra Seal Corporation
- Reason
- Failed Stability Specifications: Out-of-Specification results observed for Aspirin related compound Salicylic Acid.
- Published
- November 3, 2021
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
Xpect First aid Extra Strength PAIN AWAY (Acetaminophen 250 mg/Aspirin 250 mg/Caffeine 65 mg) tablets, 2 Tablets/package, Packaged in 12,000 Packets/Case, Material# 111519, Mfg. for: Cintas First Aid & Safety, Mason, OH 45040 (Shipping Label)
by Ultra Seal Corporation
- Reason
- Failed Stability Specifications: Out-of-Specification results observed for Aspirin related compound Salicylic Acid.
- Published
- November 3, 2021
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
Advance Formula Pain Reliever (Acetaminophen 250 mg/Aspirin 250 mg/Caffeine 65 mg) tablets, 2 tablets Per Packet, Packaged in 12,000 Packets/Case, PO# 007564-00, Item# 1170, Mfg. for: Advanced First Aid, Baltimore, MD 21237; American Safety & First Aid, Osceola, IN 46561 (Shipping Label)
by Ultra Seal Corporation
- Reason
- Failed Stability Specifications: Out-of-Specification results observed for Aspirin related compound Salicylic Acid.
- Published
- November 3, 2021
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
North by Honeywell PAIN STOPPER EXTRA STRENGTH (Acetaminophen 250 mg, Aspirin 250 mg, Caffeine 65 mg) tablets, 2 tablets per packet, Packaged in 5,000 Packets/Case, PO# B121242, Item# 853500-01, Dist. By Honeywell Safety Products USA, Smithfield, RI 02917
by Ultra Seal Corporation
- Reason
- Failed Stability Specifications: Out-of-Specification results observed for Aspirin related compound Salicylic Acid.
- Published
- November 3, 2021
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
AERO Tab PAIN RELIEVER (Acetaminophen 250 mg/Aspirin 250 mg/Caffeine 65 mg) tablets , 2 tablets Per Packet, Packaged in 10,000 Packets/Case, PO# 11938, Mfg. for: Aero Healthcare, Valley Cottage, NY 10989 (Shipping Label )
by Ultra Seal Corporation
- Reason
- Failed Stability Specifications: Out-of-Specification results observed for Aspirin related compound Salicylic Acid.
- Published
- November 3, 2021
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
ZEE+ painaid ESF Extra-Strength Formula (Acetaminophen 250 mg, Aspirin 250 mg (NSAID), Caffeine 65 mg) tablets, 2 Tablets per/package, Packaged in a) 50-count packages/carton, b) 125-count packages/carton, PA-ESF 1414Z, Dist. by: Zee Medical Distributors, LLC Mason, OH 45040 (Shipping Label)
by Ultra Seal Corporation
- Reason
- Failed Stability Specifications: Out-of-Specification results observed for Aspirin related compound Salicylic Acid.
- Published
- November 3, 2021
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
Vica-Cet BACK PAIN RELIEF (Acetaminophen 250 mg/Aspirin 250 mg/Caffeine 65 mg) tablets, 2 tablets/pk, packaged in 10,000 packets, PO# 8967, Mfg. for Tellus/The Provision First Aid Line (Shipping Label)
by Ultra Seal Corporation
- Reason
- Failed Stability Specifications: Out-of-Specification results observed for Aspirin related compound Salicylic Acid.
- Published
- November 3, 2021
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
PainAway II (Acetaminophen 250 mg/Aspirin 250 mg/Caffeine 65 mg) tablets , 2 tablets/pk, packaged in 12,000 Packets/Case, Material # 11161, Mfg. for Respond Industries First Aid, Mason, OH 45040 (Shipping Label)
by Ultra Seal Corporation
- Reason
- Failed Stability Specifications: Out-of-Specification results observed for Aspirin related compound Salicylic Acid.
- Published
- November 3, 2021
- 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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