FDA Recall
TerminatedTerminated: May 7, 2021Historical recordClass I
Drospirenone and Ethinyl Estradiol Tablets, USP, 3 mg/0.02 mg, packaged into a carton containing 3 blister cards each blister card contains 28-film coated, biconvex tablets, Rx Only, Manufactured by: Cyndea Pharma, S.L., Olvega (Soria), 42110 Spain, Distributed by: Jubilant Cadista Pharmaceuticals, Inc., Salisbury, MD, 21801 USA, NDC 59746-763-43
by Jubilant Cadista Pharmaceuticals, Inc.
- Reason
- Failed dissolution specifications : failed results at the 3-month stability time point.
- Published
- August 7, 2019
- Distribution
- Nationwide
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FDA Recall
TerminatedTerminated: March 9, 2021Historical recordClass II
Gablofen (baclofen injection), 50 mcg/mL, Single Use Syringe, Rx only, packaged in a box containing one 1 mL syringe, Distributed by: Primal Critical Care, Inc., 3950 Schelden Circle Bethlehem, PA, 18017, NDC 66794-151-01
by Piramal Critical Care, Inc.
- Reason
- Failed Impurities/Degradation Specification -This recall is being initiated as a precaution due to the presence of an unknown impurity observed during shelf life of the product.
- Published
- August 7, 2019
- Distribution
- Nationwide
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FDA Recall
TerminatedTerminated: June 9, 2023Historical recordClass II
Equate Night-time Sleep Aide (Diphenhydramine HCl), 50 mg, Alcohol Free, Berry Flavor, 12 Fl. Oz. (354 mL), OTC, Distributed by: Walmart Stores, Inc., Bentonville, AR 72716, NDC 49035-330-02, UPC 6 8113117595 1
by LNK International, Inc.
- Reason
- Microbial contamination of non-sterile product
- Published
- August 7, 2019
- Distribution
- Nationwide
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FDA Recall
TerminatedTerminated: July 16, 2020Historical recordClass II
DIVALPROEX SODIUM EXTENDED-RELEASE TABLETS, USP Tablets, 250 mg, 100 count-unit dose carton, RX only, Manufactured by Dr. Reddy's Laboratories Ltd. Bachupally - 500 090 India. Distributed by: Major Pharmaceuticals 17177 N Laurel Park Dr., Suite 233 Livonia, MI 48152. NDC # 0904-6363-61.
by MAJOR PHARMACEUTICALS
- Reason
- cGMP deviations: Product was exposed above 50% relative humidity levels during packaging operations.
- Published
- August 7, 2019
- Distribution
- Nationwide
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FDA Recall
TerminatedTerminated: September 30, 2020Historical recordClass II
Doxycycline Hyclate Tablets, USP, 100 mg, 30 Tablets per carton (3 x 10 Unit Dose Blisters), Rx Only, Distributed by: American Health Packaging, Columbus, Ohio, 43217, NDC Carton: 62584-693-21; NDC Unit Dose: 62584-693-11
by American Health Packaging
- Reason
- Failed Dissolution Specifications: Out of specification result for the dissolution test.
- Published
- August 7, 2019
- Distribution
- Nationwide
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FDA Recall
TerminatedTerminated: April 22, 2020Historical recordClass II
Timolol- Dorzolamide- Latanoprost P-F (0.5/2.0/0.005%) ophthalmic drops, packaged in 5mL bottles, Rx only, ImprimisRx NJ 1705 Route 46 West, Suite 4, Ledgewood, NJ 07852 (844) 446-6979
by ImprimisRx NJ
- Reason
- Subpotent Drug
- Published
- August 7, 2019
- Distribution
- Nationwide
View recall →
FDA Recall
TerminatedTerminated: April 22, 2020Historical recordClass II
Timolol-Latanoprost P-F (0.5/0.005%) ophthalmic drops, packaged in 5mL bottles, Rx only, ImprimisRX NJ 1705 Route 46 West, Suite 4, Ledgewood, NJ 07852 (844) 446-6979
by ImprimisRx NJ
- Reason
- Subpotent Drug
- Published
- August 7, 2019
- Distribution
- Nationwide
View recall →
FDA Recall
TerminatedTerminated: February 16, 2021Historical recordClass II
Kaitlib Fe norethindrone and ethinyl estradiol chewable tablets (0.8 mg/0.025 mg) and Ferrous Fumarate, Chewable Tablets, Rx Only, Distributed by: Lupin Pharmaceuticals, Inc. Baltimore, MD - 21202 Manufactured by: Lupin Limited Pathampur -454775 India. NDC 68180-903-11 (wallet of 28 tablets) NDC 68180-903-13 (carton of 3 wallets)
by Lupin Pharmaceuticals Inc.
- Reason
- Failed Impurities/Degradation Specifications: Kaitlib Fe Tablets has an out of specification result observed in long term stability study.
- Published
- August 7, 2019
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
TerminatedTerminated: August 26, 2019Historical recordClass II
Dolfin S.A.
- Product
- Dolfin Dark Chocolate with Pink Peppercorns Net Wt 2.47 oz…
- Reason
- Product may contain undeclared milk.
- Published
- August 7, 2019
- Distribution
- Imported to US, customers located in the…
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FDA Recall
🇺🇸 United States
TerminatedTerminated: November 22, 2019Historical recordClass II
Growers Express S
- Product
- Growers Express Cauliflower Florets 3 lb. plastic bag - Foo…
- Reason
- Firm received notification of a positive L. mono test result from a random sample taken from of one our customer's retail locations by the Massachusetts Department of Public Health.
- Published
- August 7, 2019
- Distribution
- CT, FL, IL, ME, MD, MA, NC, NY, PA, SC,…
View recall →
FDA Recall
🇺🇸 United States
TerminatedTerminated: November 22, 2019Historical recordClass II
Growers Express S
- Product
- Growers Express Cauliflower Florets 3 lb. plastic bag - Foo…
- Reason
- Firm received notification of a positive L. mono test result from a random sample taken from of one our customer's retail locations by the Massachusetts Department of Public Health.
- Published
- August 7, 2019
- Distribution
- CT, FL, IL, ME, MD, MA, NC, NY, PA, SC,…
View recall →
FDA Recall
🇺🇸 United States
TerminatedTerminated: November 22, 2019Historical recordClass II
Growers Express S
- Product
- Green Giant Fresh Brussel Sprouts 2 lb. . (454 g). plastic…
- Reason
- Firm received notification of a positive L. mono test result from a random sample taken from of one our customer's retail locations by the Massachusetts Department of Public Health.
- Published
- August 7, 2019
- Distribution
- CT, FL, IL, ME, MD, MA, NC, NY, PA, SC,…
View recall →
FDA Recall
🇺🇸 United States
TerminatedTerminated: November 22, 2019Historical recordClass II
Growers Express S
- Product
- Signature Farms, Cauliflower Crumbles, Chopped Cauliflower…
- Reason
- Firm received notification of a positive L. mono test result from a random sample taken from of one our customer's retail locations by the Massachusetts Department of Public Health.
- Published
- August 7, 2019
- Distribution
- CT, FL, IL, ME, MD, MA, NC, NY, PA, SC,…
View recall →
FDA Recall
🇺🇸 United States
TerminatedTerminated: November 22, 2019Historical recordClass II
Growers Express S
- Product
- Trader Joe's Zucchini Spirals 10.5 oz. (298 g). plastic bag…
- Reason
- Firm received notification of a positive L. mono test result from a random sample taken from of one our customer's retail locations by the Massachusetts Department of Public Health.
- Published
- August 7, 2019
- Distribution
- CT, FL, IL, ME, MD, MA, NC, NY, PA, SC,…
View recall →
FDA Recall
🇺🇸 United States
TerminatedTerminated: November 22, 2019Historical recordClass II
Growers Express S
- Product
- Trader Joe's Butternut Squash Spirals 10.5 oz. (298 g). pla…
- Reason
- Firm received notification of a positive L. mono test result from a random sample taken from of one our customer's retail locations by the Massachusetts Department of Public Health.
- Published
- August 7, 2019
- Distribution
- CT, FL, IL, ME, MD, MA, NC, NY, PA, SC,…
View recall →
FDA Recall
🇺🇸 United States
TerminatedTerminated: November 22, 2019Historical recordClass II
Growers Express S
- Product
- Green Giant Fresh Zucchini Noodles; Fresh Spiralized Zucchin…
- Reason
- Firm received notification of a positive L. mono test result from a random sample taken from of one our customer's retail locations by the Massachusetts Department of Public Health.
- Published
- August 7, 2019
- Distribution
- CT, FL, IL, ME, MD, MA, NC, NY, PA, SC,…
View recall →
FDA Recall
🇺🇸 United States
TerminatedTerminated: November 22, 2019Historical recordClass II
Growers Express S
- Product
- Growers Express Fresh Butternut Peeled; 10 lb. plastic bag…
- Reason
- Firm received notification of a positive L. mono test result from a random sample taken from of one our customer's retail locations by the Massachusetts Department of Public Health.
- Published
- August 7, 2019
- Distribution
- CT, FL, IL, ME, MD, MA, NC, NY, PA, SC,…
View recall →
FDA Recall
🇺🇸 United States
TerminatedTerminated: November 22, 2019Historical recordClass II
Growers Express S
- Product
- Green Giant Fresh Ramen Soup Bowl; Butternut squash, Caulif…
- Reason
- Firm received notification of a positive L. mono test result from a random sample taken from of one our customer's retail locations by the Massachusetts Department of Public Health.
- Published
- August 7, 2019
- Distribution
- CT, FL, IL, ME, MD, MA, NC, NY, PA, SC,…
View recall →
FDA Recall
🇺🇸 United States
TerminatedTerminated: November 22, 2019Historical recordClass II
Growers Express S
- Product
- Green Giant Fresh Butternut Squash Cubed. 32 oz. (2 lbs.) (…
- Reason
- Firm received notification of a positive L. mono test result from a random sample taken from of one our customer's retail locations by the Massachusetts Department of Public Health.
- Published
- August 7, 2019
- Distribution
- CT, FL, IL, ME, MD, MA, NC, NY, PA, SC,…
View recall →
FDA Recall
🇺🇸 United States
TerminatedTerminated: November 22, 2019Historical recordClass II
Growers Express S
- Product
- Green Giant Fresh Butternut Squash Diced. 12 oz. (340 g) pl…
- Reason
- Firm received notification of a positive L. mono test result from a random sample taken from of one our customer's retail locations by the Massachusetts Department of Public Health.
- Published
- August 7, 2019
- Distribution
- CT, FL, IL, ME, MD, MA, NC, NY, PA, SC,…
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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