FDA Recall
Terminated
Historical recordClass II
RIOMET ER (metformin hydrochloride for extended-release oral suspension), 500 mg per 5 mL 16 oz. For Oral Use Only Rx Only Manufactured by: Sun Pharmaceuticals Industries Limited Mohali, India Distributed by: Sun Pharmaceuticals Industries, Inc. Cranbury, NJ 08512 NDC 10631-019-17
by SUN PHARMACEUTICAL INDUSTRIES INC
- Reason
- CGMP Deviations: Detection of N-nitrosodimethylamine (NDMA) impurity in finished drug product.
- Published
- October 7, 2020
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Strides Pharma Inc.Potassium Chloride Extended-Release Tablets, USP 8mEq (600 mg) 100 Tablets Rx Only Manufactured by: Strides Pharma Science Limited Bengaluru -562106 India Distributed by: Strides Pharma Inc., East Brunswick NJ 08816 NDC 64380-860-06
by Strides Inc.
- Reason
- Failed Dissolution Specifications
- Published
- October 7, 2020
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
EAGLE FAMILY FOODS GROUP LLC
- Product
- Nice! Organic White Cheddar Popcorn, 4.5 oz. bag, UPC 049022…
- Reason
- Foreign material, pieces of glass may be in the product
- Published
- October 7, 2020
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
EAGLE FAMILY FOODS GROUP LLC
- Product
- Nature's Promise Organic Lightly Salted Popcorn, 6 oz. bag,…
- Reason
- Foreign material, pieces of glass may be in the product
- Published
- October 7, 2020
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
EAGLE FAMILY FOODS GROUP LLC
- Product
- Cretors Organic Extra Virgin Olive Oil Popcorn, 4.4 oz. bag,…
- Reason
- Foreign material, pieces of glass may be in the product
- Published
- October 7, 2020
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
EAGLE FAMILY FOODS GROUP LLC
- Product
- 365 Everyday Value Organic Classic Salted Popcorn, 6 oz. bag…
- Reason
- Foreign material, pieces of glass may be in the product
- Published
- October 7, 2020
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
EAGLE FAMILY FOODS GROUP LLC
- Product
- 365 Whole Foods Market Organic Reduced fat &Sodium Popcorn,…
- Reason
- Foreign material, pieces of glass may be in the product
- Published
- October 7, 2020
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
EAGLE FAMILY FOODS GROUP LLC
- Product
- 365 Whole Foods Market Organic White Cheddar Popcorn, 4 oz.…
- Reason
- Foreign material, pieces of glass may be in the product
- Published
- October 7, 2020
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Nature-Throid, 1.5 Grain, (97.5 mg), (Thyroid U.S.P. 1.5 gr. (97.5mg)/Liothyronine (T3) 13.5mcg/Levothyroxine (T4) 57mcg, 90-count bottles, Rx Only, Mfg: RLC Labs; Cave Creek, AZ, Preferred Pharmaceuticals, Inc. NDC 68788-7605-09
by Preferred Pharmaceuticals, Inc.
- Reason
- CGMP Deviations
- Published
- September 30, 2020
- Distribution
- Repackaged tablets sold to three physici…
View recall →
FDA Recall
Terminated
Historical recordClass II
Nature-Throid, 1 Grain, 65 mg (Thyroid U.S.P. 1 gr. (65mg)/Liothyronine (T3) 9mcg/Levothyroxine (T4) 38mcg, packaged in a) 90-count bottles (NDC 68788-7604-09), b) 100-count tablets (NDC 68788-7604-01), Rx Only, Mfg: RLC Labs; Cave Creek, AZ, Preferred Pharmaceuticals, Inc.
by Preferred Pharmaceuticals, Inc.
- Reason
- CGMP Deviations
- Published
- September 30, 2020
- Distribution
- Repackaged tablets sold to three physici…
View recall →
FDA Recall
Terminated
Historical recordClass II
Nature-Throid, 3/4 Grain (48.75 mg) Thyroid U.S.P. 3/4 gr. (48.75 mg)/Liothyronine (T3) 6.75mcg/Levothyroxine (T4) 28.5mcg, 90-count tablets, Rx Only, Mfg: RLC Labs; Cave Creek, AZ, Preferred Pharmaceuticals, Inc. NDC 68788-6860-09
by Preferred Pharmaceuticals, Inc.
- Reason
- CGMP Deviations
- Published
- September 30, 2020
- Distribution
- Repackaged tablets sold to three physici…
View recall →
FDA Recall
Terminated
Historical recordClass II
Nature-Throid, 1/2 Grain, 32.5 mg (Thyroid U.S.P. 1/2 gr. (32.5 mg)/Liothyronine (T3) 4.5mcg/Levothyroxine (T4) 19mch, 100-count tablets, Rx Only, Mfg: RLC Labs; Cave Creek, AZ, Preferred Pharmaceuticals, Inc. NDC 68788-9283-01
by Preferred Pharmaceuticals, Inc.
- Reason
- CGMP Deviations
- Published
- September 30, 2020
- Distribution
- Repackaged tablets sold to three physici…
View recall →
FDA Recall
Terminated
Historical recordClass I
Red-E Tablet, Proprietary Blend 3000 mg**, packaged in 1-count plastic bag stapled with cardboard labeling.
by The Protein Shoppe
- Reason
- Marketed Without An Approved NDA/ANDA: product found to be tainted with sildenafil, an FDA approved drug for the treatment of male erectile dysfunction, making this an unapproved drug fro which the safety and efficacy have not been established and therefore subject to recall.
- Published
- September 30, 2020
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Albuterol Sulfate Inhalation Aerosol, 90 mcg per actuation, 200 metered inhalations, Manufactured by: Catalent Pharma Solutions, 160 N Pharma Drive, Morrisville, NC 27560, Distributed by: Perrigo, Allegan, MI 49010 NDC 45802-088-01
by Perrigo Company PLC
- Reason
- Defective Delivery System: Sustained trend of failure to dispense complaints.
- Published
- September 30, 2020
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass I
Incredible Products Gelbac T Antibacterial Hand Gel (ethyl alcohol 80%), Kills 99.9% bacteria and germs, a) 4.2 Oz./125 mL bottle, NDC: 71761-000-00, UPC: 7502278002555, Distributed by Pacific Coast Global Inc. Chula Vista, CA 91911, Made in Mexico b) 33.8 Oz./1 L, UPC: 7502278002586, Made in Mexico By Incredible Products S.A. de C.V. alle Castellanos y Tapia 921, Oblatos, 44350 Guadalajara, Jal, MX.
by Incredible Products, SA de CV
- Reason
- Chemical Contamination: Product contains methanol as an active ingredient and is sub-potent for ethanol.
- Published
- September 30, 2020
- Distribution
- CA and GA
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
Toufayan Bakery, Inc.
- Product
- Goodie Girl, Gluten Free Magical Animal Crackers, 7 ounce ,…
- Reason
- Gluten free product was mixed with wheat containing product. Undeclared Wheat.
- Published
- September 30, 2020
- Distribution
- The product was distributed to the follo…
View recall →
FDA Recall
Terminated
Historical recordClass I
Nature Throid, 1.5 Grain (97.5 mg) Thyroid USP [Liothyronine (T3) 13.5 mcg, Levothyroxine (T4) 57 mcg], packaged in a) 30-count bottles (NDC 64727-3305-4), b) 60-count bottles (NDC 64727-3305-5), c) 90-count bottles (NDC 64727-3305-6), and 100-count bottles (NDC 64727-3305-1), Rx only, Manufactured by: RLC Labs Phoenix, AZ 85024, NDC 64727-3305-1
by RLC Labs Inc.
- Reason
- Subpotent Drug: FDA analysis found product to be subpotent
- Published
- September 23, 2020
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass I
Nature Throid, 2 Grain (130 mg) Thyroid USP [Liothyronine (T3) 18 mcg, Levothyroxine (T4) 76 mcg], packaged in a) 30-count bottles (NDC 64727-3308-4) and b)100-count bottles (NDC 64727-3308-1), Rx only, Manufactured by: RLC Labs Phoenix, AZ 85024
by RLC Labs Inc.
- Reason
- Subpotent Drug: FDA analysis found product to be subpotent
- Published
- September 23, 2020
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass I
Nature Throid, 1.25 Grain (81.25 mg) Thyroid USP [Liothyronine (T3) 11.25 mcg, Levothyroxine (T4) 47.5 mcg], 100-count bottles, Rx only, Manufactured by: RLC Labs Phoenix, AZ 85024, NDC 64727-3303-1
by RLC Labs Inc.
- Reason
- Subpotent Drug: FDA analysis found product to be subpotent
- Published
- September 23, 2020
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass I
Nature Throid, 3/4 Grain (48.75 mg) Thyroid USP [Liothyronine (T3) 6.75 mcg, Levothyroxine (T4) 28.5 mcg], packaged in a) 100-count bottles (NDC 64727-3302-1) and b) 1000-count bottles (NDC 64727-3302-2), Rx only, Manufactured by: RLC Labs Phoenix, AZ 85034
by RLC Labs Inc.
- Reason
- Subpotent Drug: FDA analysis found product to be subpotent
- Published
- September 23, 2020
- 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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