FDA Recall
TerminatedTerminated: October 3, 2023Historical recordClass I
Piperacillin and Tazobactam for Injection, USP 3.375 gram/vial* 10-count Single Use Vials per carton, Rx Only, Mfg. by: Hospira Healthcare India Pvt. Ltd. Irungattukottai-602 105, India Mfg. for: Apotex Corp. Weston, FL 33326. NDC 60505-0687-4
by Apotex Inc.
- Reason
- Subpotent Drug: High Levels of Impurities Resulting in Decrease Potency
- Published
- May 23, 2018
- Distribution
- Nationwide
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FDA Recall
TerminatedTerminated: February 28, 2019Historical recordClass III
Riomet (metformin hydrochloride oral solution), 500 mg/5 mL (16 fl. oz.), 473 mL plastic bottle, Manufactured by: Mikart, Inc., Atlanta, GA 30318, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512. NDC 10631-206-02
by Sun Pharmaceutical Industries, Inc.
- Reason
- Labeling: Not Elsewhere Classified: Sun Pharma has decided to initiate this recall in response to identified labeling discrepancies in the patient literature.
- Published
- May 23, 2018
- Distribution
- Nationwide
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FDA Recall
TerminatedTerminated: December 10, 2018Historical recordClass II
Hydrocortisone Ointment, USP 2.5%, Net Wt. 20g, Rx Only, Manufactured By Perrigo, Bronx, NY 10457, Distributed by Perrigo, Allegan MI 49010, NDC 45802-014-02
by Perrigo New York
- Reason
- Failed Stability Specifications
- Published
- May 23, 2018
- Distribution
- Nationwide
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FDA Recall
TerminatedTerminated: September 28, 2020Historical recordClass II
Scopolamine Transdermal Therapeutic System, 1 mg/3 days, a) 4-count (NDC 45802-580-84); b) 10-count (NDC 45802-580-46); c) 24-count (NDC 45802-580-62), Rx only, Mfd. by: Aveva Drug Delivery Systems, A Nitto Denko Company, Miramar, FL 33025 Distributed by Perrigo, Allegan, MI 49010
by L. Perrigo Company
- Reason
- Defective delivery system
- Published
- May 23, 2018
- Distribution
- Nationwide
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FDA Recall
TerminatedTerminated: October 31, 2018Historical recordClass II
Kit for the Preparation of Technetium TC-99M Mebrofenin, 45 mg in 10 mL (5 count), NDC 45567-0455-1 and (30 count), NDC 45567-0455-2 . Manufactured by: Pharmalucence, Inc., Billerica, MA 01821.
by Pharmalucence, Inc.
- Reason
- Failed Stability Specifications
- Published
- May 23, 2018
- Distribution
- Nationwide
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FDA Recall
TerminatedTerminated: January 8, 2020Historical recordClass III
Calendula Cream, calendula officinalis 1X HUS-10%, 2.5 oz. tubes, Distributed by Boiron Inc., Newtown Square, PA
by Boiron Inc.
- Reason
- Labeling: Labeling Error on Declared Strength; The outer carton (secondary packaging) statement of ingredients misstates the concentration of active ingredient at 7%. The primary packaging (tube) correctly states the active ingredient at 10%.
- Published
- May 23, 2018
- Distribution
- Nationwide
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FDA Recall
TerminatedTerminated: February 28, 2019Historical recordClass II
Sulfamethoxazole and Trimethoprim Tablets USP, 800 mg/160 mg, Rx Only, 500-count bottle, Mfg. by: Frontida BioPharm, Inc., 1100 Orthodox St., Philadelphia, PA 19124, Dist, by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512. NDC 53489-146-05
by Sun Pharmaceutical Industries, Inc.
- Reason
- Presence of Foreign Substance:Sun Pharma is recalling one (1) lot of Sulfamethoxazole and Trimethoprim Tablets USP, 800 mg/160 mg (500 ct.) because a foreign matter identified as polyethylene was detected in two (2) tablets.
- Published
- May 23, 2018
- Distribution
- Nationwide
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FDA Recall
🇺🇸 United States
TerminatedTerminated: March 15, 2019Historical recordClass I
Ethnic Foods, Inc. d/b/a Bombay Kitchen Foods
- Product
- Bombay Kitchen Bhavnagri Mix, packaged in a 19 oz., clear ba…
- Reason
- Product contains undeclared peanuts.
- Published
- May 23, 2018
- Distribution
- Multiple states
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FDA Recall
🇺🇸 United States
TerminatedTerminated: October 12, 2018Historical recordClass I
eBars
- Product
- WOMAN ORGANIC DARK CHOCOLATE BERRY bar NET WT. 1.8 OZ (51g)…
- Reason
- The product test positive for peanut allergen which is not declared on the product label.
- Published
- May 23, 2018
- Distribution
- Product was shipped to the following sta…
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FDA Recall
🇺🇸 United States
TerminatedTerminated: October 12, 2018Historical recordClass I
eBars
- Product
- TRIM ORGANIC DARK COCOA RASPBERRY bar NET WT. 1.8 OZ (51g) M…
- Reason
- The product test positive for peanut allergen which is not declared on the product label.
- Published
- May 23, 2018
- Distribution
- Product was shipped to the following sta…
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FDA Recall
🇺🇸 United States
TerminatedTerminated: October 12, 2018Historical recordClass I
eBars
- Product
- TRIM ORGANIC CHOCOLATE ALMOND bar NET WT. 1.6 OZ (45g) Manuf…
- Reason
- The product test positive for peanut allergen which is not declared on the product label.
- Published
- May 23, 2018
- Distribution
- Product was shipped to the following sta…
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FDA Recall
🇺🇸 United States
TerminatedTerminated: October 12, 2018Historical recordClass I
eBars
- Product
- RUN ORGANIC DARK COCOA RASPBERRY bar NET WT. 1.6 OZ (45g) Ma…
- Reason
- The product test positive for peanut allergen which is not declared on the product label.
- Published
- May 23, 2018
- Distribution
- Product was shipped to the following sta…
View recall →
FDA Recall
🇺🇸 United States
TerminatedTerminated: October 12, 2018Historical recordClass I
eBars
- Product
- RUN ORGANIC CHOCOLATE ALMOND bar NET WT. 1.6 OZ (45g) Manufa…
- Reason
- The product test positive for peanut allergen which is not declared on the product label.
- Published
- May 23, 2018
- Distribution
- Product was shipped to the following sta…
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FDA Recall
🇺🇸 United States
TerminatedTerminated: October 12, 2018Historical recordClass I
eBars
- Product
- MAN ORGANIC CHOCOLATE ALMOND bar NET WT. 1.8 OZ (51g) Manufa…
- Reason
- The product test positive for peanut allergen which is not declared on the product label.
- Published
- May 23, 2018
- Distribution
- Product was shipped to the following sta…
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FDA Recall
🇺🇸 United States
TerminatedTerminated: October 12, 2018Historical recordClass I
eBars
- Product
- HEAL ORGANIC CHOCOLATE PEANUT bar NET WT. 1.6 OZ (45g) Manuf…
- Reason
- The product test positive for almond allergen which is not declared on the product label.
- Published
- May 23, 2018
- Distribution
- Product was shipped to the following sta…
View recall →
FDA Recall
🇺🇸 United States
TerminatedTerminated: October 12, 2018Historical recordClass I
eBars
- Product
- GOLF ORGANIC DARK COCOA RASPBERRY bar NET WT. 1.6 OZ (45g) M…
- Reason
- The product test positive for peanut allergen which is not declared on the product label.
- Published
- May 23, 2018
- Distribution
- Product was shipped to the following sta…
View recall →
FDA Recall
🇺🇸 United States
TerminatedTerminated: October 12, 2018Historical recordClass I
eBars
- Product
- GOLF ORGANIC CHOCOLATE ALMONDS bar NET WT. 1.6 OZ (45g) Manu…
- Reason
- The product test positive for peanut allergen which is not declared on the product label.
- Published
- May 23, 2018
- Distribution
- Product was shipped to the following sta…
View recall →
FDA Recall
🇺🇸 United States
TerminatedTerminated: October 12, 2018Historical recordClass I
eBars
- Product
- FOCUS FOR KIDS! SUNFLOWER SEED CHOCOLATE STRAWBERRY bar NET…
- Reason
- The product test positive for peanuts and almond allergen which is not declared on the product label.
- Published
- May 23, 2018
- Distribution
- Product was shipped to the following sta…
View recall →
FDA Recall
🇺🇸 United States
TerminatedTerminated: October 12, 2018Historical recordClass I
eBars
- Product
- FOCUS ORGANIC CHOCOLATE PEANUT bar NET WT. 1.6 OZ (45g) Manu…
- Reason
- The firm was notified by the State of TN that the product contained undeclared almonds.
- Published
- May 23, 2018
- Distribution
- Product was shipped to the following sta…
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FDA Recall
🇺🇸 United States
TerminatedTerminated: October 12, 2018Historical recordClass I
eBars
- Product
- FIT ORGANIC PEANUT BUTTER CHOCOLATE RASPBERRY bar NET WT 1.8…
- Reason
- The firm was notified by the State of TN that the product contained undeclared almonds.
- Published
- May 23, 2018
- Distribution
- Product was shipped to the following sta…
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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