Drug Recall
Ongoing
Historical recordClass II
Methylphenidate Hydrochloride Chewable Tablets, 2.5 mg, 100-count bottle, Rx Only, Manufactured for: Rising Pharmaceuticals Inc., Saddle Brook, NJ 07863, NDC 64980-221-01
by RISING PHARMACEUTICALS
- Reason
- Failed Tablet Specifications: Recall of this drug product was voluntarily initiated by the manufacturer due to a market complaint, which stated that a tablet in the sealed bottle was twice larger in size when compared to the remaining tablets. This complaint is second of its kind.
- Recall initiated
- February 7, 2022
- Reported by FDA
- March 2, 2022
- Distribution
- Nationwide in the USA
View recall →
Drug Recall
Terminated
Historical recordClass II
Prevantics (chlorhexidine gluconate and isopropyl alcohol) Swabstick, 3.15% w/v and 70% v/v, packaged as a) One Swabstick, 0.054 fl. oz. (1.6 mL) Each in a pouch, NDC 10819-4077-1; 50 Individual Swabsticks per carton, 10 boxes of 50 Individual Swabsticks per case, REORDER NO. S40750, NDC 10819-4077-4; b) One Swabstick, 0.054 fl. Oz. (1.6 mL) Each in a pouch, 500 Individual Swabsticks per case, REORDER NO. S32450, NDC 10819-4077-2; c) One Swabstick, 0.054 fl. Oz. (1.6 mL) Each in a pouch, 500 Individual Swabsticks per case, REORDER NO. S42850, NDC 10819-4077-3; Professional Disposables International, Inc., Orangeburg, NY 10962-1376.
by Professional Disposables International, Inc.
- Reason
- cGMP deviations: uncertainty of the adequacy of the validation of the test methods used to manufacture the products.
- Recall initiated
- February 4, 2022
- Reported by FDA
- March 2, 2022
- Distribution
- Product was distributed nationwide in the USA and Puerto Rico.
View recall →
Drug Recall
Terminated
Historical recordClass II
Prevantics (chlorhexidine gluconate and isopropyl alcohol) Swab, 3.15% w/v and 70% v/v, packaged as a) One Swab, 0.034 fl. Oz. (1 mL) Each in a pouch, 100 Individual Swabs per carton, 10 boxes of 100 Individual Swabs per case, REORDER NO. B10800, NDC 10819-1080-1; b) One Swab, 0.034 fl. oz. (1 mL) Each in a pouch, 3000 Individual Swabs per case, REORDER NO. B11400, NDC 10819-1080-2; Professional Disposables International, Inc., Orangeburg, NY 10962-1376.
by Professional Disposables International, Inc.
- Reason
- cGMP deviations: uncertainty of the adequacy of the validation of the test methods used to manufacture the products.
- Recall initiated
- February 4, 2022
- Reported by FDA
- March 2, 2022
- Distribution
- Product was distributed nationwide in the USA and Puerto Rico.
View recall →
Drug Recall
Terminated
Historical recordClass II
Prevantics (chlorhexidine gluconate and isopropyl alcohol) Maxi Swabstick, 3.15% w/v and 70% v/v, packaged as a) One Maxi Swabstick, 0.172 fl. Oz. (5.1 mL) Each in a pouch, 30 Individual Maxi Swabsticks per carton, 10 boxes of 30 Individual Swabsticks per case, NDC 10819-4076-4, REORDER NO. S41950; b) One Maxi Swabstick, 0.172 fl. Oz. (5.1 mL) Each in a pouch, 300 Individual Swabsticks per case, NDC 10819-4076-3, REORDER NO. S27350; Professional Disposables International, Inc., Orangeburg, NY 10962-1376.
by Professional Disposables International, Inc.
- Reason
- cGMP deviations: uncertainty of the adequacy of the validation of the test methods used to manufacture the products.
- Recall initiated
- February 4, 2022
- Reported by FDA
- March 2, 2022
- Distribution
- Product was distributed nationwide in the USA and Puerto Rico.
View recall →
Drug Recall
Terminated
Historical recordClass III
Norepinephrine bitartrate 16 mg in 250 mL NaCl 0.9%, packaged in IV bags, Rx only, BayCare Central Pharmacy 7802 E. Telecom Parkway Temple Terrace, FL 33637 (813) 901-6392
by BayCare Integrated Service Center, LLC /dba BayCare Central Pharmacy
- Reason
- Subpotent drug
- Recall initiated
- February 14, 2022
- Reported by FDA
- March 2, 2022
- Distribution
- Florida
View recall →
Drug Recall
Terminated
Historical recordClass II
Erythromycin Topical Gel USP, 2%, Net Wt 30 g tube, Rx only, Manufactured by: Teligent Pharma, Inc., Buena, NJ 08310, Distributed by: McKesson Corporation, dba Sky Packaging, 4971 Southridge Blvd., Suite 101, Memphis, TN 38141, NDC 63739-053-66.
by Teligent Pharma, Inc.
- Reason
- Failed Impurities/Degradation Specifications: Lot not meeting specification for Unknown Max Related Compounds.
- Recall initiated
- February 7, 2022
- Reported by FDA
- February 23, 2022
- Distribution
- Nationwide in the USA.
View recall →
Drug Recall
Terminated
Historical recordClass I
HCG 6,000iu (lyo) Human Chorionic Gonadotropin Inj., For Sub-Q or IM Use Only, Not For IV Use, Vial, Rx Only, Compounded By: Revive Rx 3831 Golf Dr., Houston, TX 77018, NDC: 88888-1739-01.
by Revive Rx LLC dba Revive Rx Pharmacy
- Reason
- Non-sterility; bacterial contamination identified as Paenibacillus lautus.
- Recall initiated
- February 11, 2022
- Reported by FDA
- February 23, 2022
- Distribution
- Nationwide in the US.
View recall →
Drug Recall
Terminated
Historical recordClass I
PARAGARD T380A (intrauterine copper contraceptive), 1 unit per carton together with an insertion tube and solid white rod in a Tyvek polyethylene pouch, Rx Only, Manufactured by Teva Women's Health Inc. a subsidiary of Teva Pharmaceuticals USA, Inc., North Wales, PA 19454, NDC 51285-204-01
by CooperSurgical, Inc
- Reason
- Non-sterility
- Recall initiated
- February 4, 2022
- Reported by FDA
- February 23, 2022
- Distribution
- US Nationwide
View recall →
Drug Recall
Terminated
Historical recordClass I
RED MAMMOTH capsules, 400 mg, packaged in 10-count blisters per carton, ASIN B00KA8FBNI, barcode X001ANE0I5.
by Celebrate Today
- Reason
- Marketed Without An Approved NDA/ANDA: Product was found to contain undeclared sildenafil and tadalafil, ingredients found in FDA approved products for the treatment of male sexual enhancement, making this an unapproved drug.
- Recall initiated
- February 8, 2022
- Reported by FDA
- February 23, 2022
- Distribution
- Product was distributed nationwide in the USA via Amazon Marketplace
View recall →
Drug Recall
Terminated
Historical recordClass I
Morphine Sulfate PF 25 mg/25mL (1 mg/mL) in NaCl, 25 mL in 30 mL Single Dose Syringe, Rx only, STAQ Pharma, Inc., Denver, CO 80239, NDC: 73177-0105-04.
by STAQ Pharma, Inc.
- Reason
- Labeling: Label Mix up; A limited number of syringes containing HYDROmorphone HCl PF were incorrectly labeled as Morphine Sulfate PF with lot number 21104221A
- Recall initiated
- February 3, 2022
- Reported by FDA
- February 23, 2022
- Distribution
- CO, OH, and TX.
View recall →
Drug Recall
Terminated
Historical recordClass I
HYDROmorphone HCl PF 10 mg/50 mL (0.2mg/mL) in NaCl, 50 mL in 50 mL Single Dose Syringe, Rx only, STAQ Pharma, Inc., Denver, CO 80239, NDC: 73177-0104-05.
by STAQ Pharma, Inc.
- Reason
- Labeling: Label Mix up; A limited number of syringes containing HYDROmorphone HCl PF were incorrectly labeled as Morphine Sulfate PF with lot number 21104221A
- Recall initiated
- February 3, 2022
- Reported by FDA
- February 23, 2022
- Distribution
- CO, OH, and TX.
View recall →
Drug Recall
Terminated
Historical recordClass I
THE RED PILL, EXTRA STRENGTH capsules, 800 mg, packaged in 10-count blisters packaged in a carton, ASIN B0847BSQQ5, Barcode X002G5GMJ1.
by Your Favorite Shop
- Reason
- Marketed Without An Approved NDA/ANDA: Product was found to contain undeclared tadalafil, an ingredient found in FDA approved products for the treatment of male sexual enhancement, making this an unapproved drug.
- Recall initiated
- February 8, 2022
- Reported by FDA
- February 23, 2022
- Distribution
- Product was distributed nationwide in the USA via the internet through Amazon Marketplace.
View recall →
Drug Recall
Terminated
Historical recordClass II
Chlorthalidone Tablets USP 25 mg, Rx Only, 100 Tablets, Sun Pharma, Mfg. by: Fontida Bio Pharm Inc., 1100 Orthodox St. Philadephia, PA 19124, Dist. by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, NDC 57664-648-88.
by SUN PHARMACEUTICAL INDUSTRIES INC
- Reason
- Foreign Matter identified as stainless steel microscopic wear particles mixed with punch lubricant oil and silicone particles from the dust cup
- Recall initiated
- February 7, 2022
- Reported by FDA
- February 23, 2022
- Distribution
- Nationwide with the United States
View recall →
Drug Recall
Terminated
Historical recordClass II
Pyrazinamide Tablets, USP 500 mg, 100-count bottles, Rx only, Manufactured by: ULTRAtab Laboratories, Inc. Highland, NY 12528, Distributed by Par Pharmaceuticals, Chestnut Ridge, NY 10977, NDC 67253-660-10.
by ANI Pharmaceuticals, Inc.
- Reason
- cGMP Deviations
- Recall initiated
- February 15, 2022
- Reported by FDA
- February 23, 2022
- Distribution
- Nationwide within the United States
View recall →
Drug Recall
Terminated
Historical recordClass II
Alprazolam Tablets, USP 2.0 mg, packaged in a) 100-count bottles (NDC 67253-903-10), b) 500-count bottles (NDC 67253-903-50), Rx only, Distributed by: Par Pharmaceutical Chestnut Ridge, NY 10977
by ANI Pharmaceuticals, Inc.
- Reason
- cGMP Deviations
- Recall initiated
- February 15, 2022
- Reported by FDA
- February 23, 2022
- Distribution
- Nationwide within the United States
View recall →
Drug Recall
Terminated
Historical recordClass II
Alprazolam Tablets, USP 1.0 mg, packaged in a) 100-count bottles (NDC 67253-902-10), b) 500-count bottles (NDC 67253-902-50), and c) 1000-count bottles (NDC 67253-902-11), Rx only, Distributed by: Par Pharmaceutical Chestnut Ridge, NY 10977
by ANI Pharmaceuticals, Inc.
- Reason
- cGMP Deviations
- Recall initiated
- February 15, 2022
- Reported by FDA
- February 23, 2022
- Distribution
- Nationwide within the United States
View recall →
Drug Recall
Terminated
Historical recordClass II
Alprazolam Tablets, USP 0.5 mg, packaged in a) 100-count bottles (NDC 67253-901-10), b) 500-count bottles (NDC 67253-901-50), and c) 1000-count bottles (NDC 67253-901-11), Rx only, Distributed by: Par Pharmaceutical Chestnut Ridge, NY 10977
by ANI Pharmaceuticals, Inc.
- Reason
- cGMP Deviations
- Recall initiated
- February 15, 2022
- Reported by FDA
- February 23, 2022
- Distribution
- Nationwide within the United States
View recall →
Drug Recall
Terminated
Historical recordClass II
Alprazolam Tablets, USP 0.25 mg, packaged in a) 100-count bottles (NDC 67253-900-10), b) 500-count bottles (NDC 67253-900-50), and c) 1000-count bottles (NDC 67253-900-11), Rx only, Distributed by: Par Pharmaceutical Chestnut Ridge, NY 10977
by ANI Pharmaceuticals, Inc.
- Reason
- cGMP Deviations
- Recall initiated
- February 15, 2022
- Reported by FDA
- February 23, 2022
- Distribution
- Nationwide within the United States
View recall →
Drug Recall
Terminated
Historical recordClass I
MAC DADDY PURPLE Capsules, packaged in 10-count blisters per carton, ASIN B08Z63Z4QK, UPC 742137 605764.
by ABC Sales 1 Inc
- Reason
- Marketed Without An Approved NDA/ANDA: product was found to contain undeclared tadalafil and/or sildenafil, ingredients found in FDA approved products for the treatment of male sexual enhancement, making these unapproved drugs.
- Recall initiated
- February 8, 2022
- Reported by FDA
- February 23, 2022
- Distribution
- Product was distributed nationwide in the USA via Amazon Marketplace.
View recall →
Drug Recall
Terminated
Historical recordClass I
MAC DADDY RED Capsules, packaged in 10-count blisters per carton, ASIN B07TLDZLY2, UPC 742137 605191.
by ABC Sales 1 Inc
- Reason
- Marketed Without An Approved NDA/ANDA: product was found to contain undeclared tadalafil and/or sildenafil, ingredients found in FDA approved products for the treatment of male sexual enhancement, making these unapproved drugs.
- Recall initiated
- February 8, 2022
- Reported by FDA
- February 23, 2022
- Distribution
- Product was distributed nationwide in the USA via Amazon Marketplace.
View recall →
This information is republished from FDA's Recall Enterprise System through openFDA. Public Health Trace
does not verify or supplement it, is not affiliated with the FDA, and does not provide medical advice --
always follow the guidance of your pharmacist, physician, or the recalling company for any medication you take.
Read the full medical disclaimer.
