Drug Recall Enforcement Reports

What are the Drug Enforcement Reports?

All drug recalls are monitored by the Food and Drug Administration (FDA) and are included in the Enforcement Report once they are properly classified. The FDA will determine if a firm's removal or correction actions of a marked product meet the requirements to be considered a "recall". The FDA will also determine the public hazard assessment and a recall classification will be published in the Enforcement Report.

The Drug Enforcement Reports included in this listing was last updated on 01-20-2022 and include a total of 13417 recall reports.

Recall Number Initiation Date Product Description Recall Reason Recall Firm / Quantity Recall Classification Status
D-0358-202212-29-2021Oxycodone Hydrochloride Tablets, USP C-II, 5 mg, 100 count bottles, Rx Only, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, MD 21202. Manufactured by: Novel Laboratories, Inc. Somerset, NJ 08873. NDC 43386-432-01
Package NDCs: 43386-432-03; 43386-432-01; 43386-432-05; 43386-433-03; 43386-433-01; 43386-433-05; 43386-430-05; 43386-430-03; 43386-430-01; 43386-434-05; 43386-434-03; 43386-434-01; 43386-431-03; 43386-431-01; 43386-431-05
Out-of-specification impurity test result observed at 18-month long term stability time point.Lupin Pharmaceuticals Inc. / 23,965 100 count bottlesClass IIIOngoing
D-0360-202212-29-2021Cefixime 400 mg capsule, packaged in a) 2-count bottle (NDC 70518-2749-02), b) 2-count blister pack (NDC 70518-2749-03), Rx only, MFG: Ascend Labs, LLC, Montvale, NJ 07645Failed Impurities/Degradation SpecificationsRemedyRepack Inc. / a) 716 bottles/ 1432 capsules b) 223 blister packs/ 466 capsulesClass IIOngoing
D-0326-202212-22-2021Gatifloxacin Ophthalmic Solution, 0.5%, 2.5 mL bottle, Rx only, Manufactured by: Lupin Limited, Pithampur (M.P.) 454 775, INDIA, NDC 68180-435-01.
Package NDCs: 68180-435-01
Failed Stability Specifications: Out-of-specification results observed in a water loss test that might affect the assay content and alter drug concentration.Lupin Pharmaceuticals Inc. / 50,832 bottlesClass IIIOngoing
D-0359-202212-21-2021Cefixime Capsules, 400 mg, 50-count bottles, Rx only, Manufactured by: Alkem Laboratories Ltd., Mumbai, India, Distributed by: Ascend Laboratories, LLC, Parsippany, NJ, NDC 67877-584-50
Package NDCs: 67877-584-50; 67877-584-01; 67877-584-05
Failed impurities/degradation specificationsAscend Laboratories, LLC / 42,698 bottlesClass IIOngoing
D-0294-202212-16-2021Penicillin V Potassium for Oral Solution, USP 125 mg (200,000 U) per 5 mL a) 100 mL (NDC 00093-4125-73) and b) 200 mL (NDC 00093-4125-74) (when mixed) bottles, Rx Only, Manufactured For: Teva Pharmaceuticals USA, Inc. North Wales, PA 19454SubpotentTeva Pharmaceuticals USA / a) 86,790 and b) 25,416 bottlesClass IIOngoing
D-0363-202212-06-2021kleantouch HAND SANITIZER (ethyl alcohol 70%), 8.0 FL OZ (236 ML), pump bottles, Distributed by: Valisa MFG, LLC, Farmingdale, NY, 11735, Made in USA, UPC 6 86162 99246 1Marketed Without an Approved NDA/ANDA: Product labeled to contain methanol making it an unapproved new drug and contains methanolValisa MFG LLC / 7704 bottlesClass IOngoing
D-0299-202212-03-2021Veklury (remdesivir) for injection, 100 mg/vial, Single-Dose Vial, Rx only, Manufactured for: Gilead Sciences, Inc., Foster City, CA 94404, NDC 61958-2901-2Presence of Particulate Matter: investigation into a customer complaint confirmed the presence of glass particulates.Gilead Sciences, Inc. / 53,473 vialsClass IOngoing
D-0284-202212-03-2021B-Complex, injection, 1 mL vials, Rx only, Cape Drugs 1384 Cape St. Claire Road Annapolis, MD 21409Lack of Processing ControlsValgene Incorporated dba Cape Drugs / 12 vialsClass IICompleted
D-0283-202212-03-2021Methylcobalamin 12mg/ml injection, 1 mL vials, Rx only, Cape Drugs 1384 Cape St. Claire Road Annapolis, MD 21409Lack of Processing ControlsValgene Incorporated dba Cape Drugs / 27 vialsClass IICompleted
D-0285-202212-01-2021Telmisartan and Hydrochlorothiazide Tablets, USP, 40 mg/12.5 mg, 30 count bottles, Rx only, Manufactured by: Torrent Pharmaceuticals LTD., Indrad-382 721, India. Manufactured for: Torrent Pharma Inc., Basking Ridge, NJ 07920. NDC: 13668-159-30
Package NDCs: 13668-159-30; 13668-159-01; 13668-159-74; 13668-159-72; 13668-160-30; 13668-160-01; 13668-160-74; 13668-160-72; 13668-161-74; 13668-161-01; 13668-161-72; 13668-161-30
Superpotent; HydrochlorothiazideTorrent Pharma Inc. / 27,312 BottlesClass IIIOngoing
D-0265-202211-30-20215% Dextrose Injection, USP, 50 mL ADD-Vantage Unit, Rx only, Distributed by Hospira, INC., Lake Forest, IL 60045 USA, NDC 0409-7100-68/0409-7100-66
Package NDCs: 0409-7100-68; 0409-7100-66; 0409-7100-69; 0409-7100-67; 0409-7100-04; 0409-7100-02
Lack of sterility assurance: bag has the potential to leak.Pfizer Inc. / 765 bagsClass IIOngoing
D-0295-202211-30-2021Lidocaine Hydrochloride, Topical Solution USP, 4% (40 mg/mL), packaged in 50 mL screw cap bottles, 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 63739-997-64
Package NDCs: 63739-997-64
Superpotent DrugTeligent Pharma, Inc. / 6,816 bottlesClass IOngoing
D-0296-202211-30-2021Lidocaine Hydrochloride, Topical Solution USP, 4% (40 mg/mL), packaged in 50 mL screw cap bottles, 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 63739-997-64
Package NDCs: 63739-997-64
Superpotent Drug: Minimally superpotentTeligent Pharma, Inc. / 7,176 bottlesClass IIOngoing
D-0298-202211-30-2021Klean Touch Hand Sanitizer (Ethyl Alcohol 70%) Ingredients Ethanol and Methanol, in 55-gallon drums, Aroma Release Technology, Inc., 7026 Discovery Drive, Chattanooga, TN 37416Marketed Without an Approved NDA/ANDA: Product labeled to contain methanol making it an unapproved new drug and contains methanolAroma Release Technologies Inc / 37 55-gallon drumsClass IOngoing
D-0327-202211-29-2021PAIN AID ESF- (Acetaminopehn USP 250mg, Asprin USP 250mg Caffeine 65mg) coated, bulk OTC tablets packaged in corrugated boxes lined with 2 polyethylene bags 100 lb, ULTRAtab Laboratories, Inc. NDC# 62959-560-00, Product Code M560LCGMP Deviations: failed stability results, inadequate laboratory investigations,ULTRAtab Laboratories, Inc. / 14 bulk lots (approximately 1,987,951 tablets each)Class IIOngoing
D-0288-202211-29-2021Moxifloxacin, 1 mg/mL, 1mL in 2mL vial, solution for intracameral injection, 10 vials/carton, Rx only, Leiters 13796 Compark Blvd, Englewood, CO 80112, (800) 292-6772, NDC 71449-096-42Labeling: Label Mix-up: Vials labeled as moxifloxacin 1 mg/mL may actually contain moxifloxacin 5 mg/mLDenver Solutions, LLC DBA Leiters Health / 1440 vialsClass IIOngoing
D-0278-202211-29-2021Diclofenac Sodium Topical Solution, 1.5% w/w, packaged in 150 mL bottles, Rx only, Mfg: SOLA Pharmaceuticals Preferred Pharmaceuticals, Inc., NDC 68788-7707-01Defective container: Out of specification for container integrity leading to bottles leaking.Preferred Pharmaceuticals, Inc. / 72 bottlesClass IIOngoing
D-0264-202211-19-2021Tydemy (drospirenone, ethinyl estradiol & levomefolate calcium tablets, 3 mg/0.03 mg/0.451 mg and levomefolate calcium tablets, 0.451 mg), packaged in cartons containing 3 wallets of 28 Tablets each, Rx Only, Distributed by: Lupin Pharmaceuticals, Inc., Baltimore, Maryland 21202, United Stated, Manufactured by: Lupin Limited, Pithampur, (M.P.) - 454775, India, 244896, The individual wallet NDC 68180-904-11 and the carton NDC 68180-904-13.Subpotent DrugLupin Pharmaceuticals Inc. / 4113 cartonsClass IIIOngoing
D-0266-202211-19-2021AmericanScreening HAND SANITIZER (ethyl alcohol 70%) ANTIMICROBIAL FORMULA Vitamin E & Moisturizer, 8 FL OZ (237 mL) bottle with either a black or clear top, Distributed by American Screening LLC Shreveport, LA, 71106 UPC 8 40050 51579 2Labeling Not Elsewhere Classified: Hand sanitizer packaged in containers resembling drinking water bottles.American Screening LLC / 153,336 bottlesClass IOngoing
D-0276-202211-19-2021Hydrocodone Bitartrate and Acetaminophen Tablets, USP 10 mg/325 mg, 100-count bottle, Rx only, Manufactured for: Camber Pharmaceuticals, Inc. Piscataway, NJ 08854, Manufactured by: Ascent Pharmaceuticals, Inc., Central Islip, NY 11722, NDC 31722-997-01.
Package NDCs: 31722-996-01; 31722-996-05; 31722-997-01; 31722-997-05
Product Mix-upAscent Pharmaceuticals, Inc. / 9744 bottlesClass IIOngoing
D-0262-202211-17-2021Ascorbic Acid Solution for Injection, 500 mg/mL, 50 mL Multiple Dose Vial, For IM, IV or SC Use Only, Rx only, ASP Cares, 2414 Babcock Rd Ste #106, San Antonio, TX 78229 NDC 72833-690-50Lack of Assurance of SterilityASP CARES / 3077 vialsClass IIOngoing
D-0261-202211-17-2021Biotin Solution for Injection, 10 mg/mL, 30 mL Multiple Dose Vial, Sterile, For IM or IV use only, Rx only ASP Cares, 2414 Babcock Rd Ste #106, San Antonio, TX 78229 NDC 72833-0589-30Lack of Assurance of SterilityASP CARES / 896 vialsClass IIOngoing
D-0260-202211-17-2021Methylcobalamin Solution for Injection, 1 mg/mL, 30 mL Multiple Dose Vial, For IM, SC or IV Use Only, Rx only, ASP Cares2414 Babcock Rd Ste #106, San Antonio, TX 78229 NDC 72833-565-30Lack of Assurance of SterilityASP CARES / 1605 vialsClass IIOngoing
D-0286-202211-17-2021Enoxaparin Sodium Injection, USP, 40 mg/0.4 mL, Single-Dose Syringes with Automatic Safety Device, For Subcutaneous Injection, Rx Only; 0.4 mL Syringes, Manufactured for Sandoz Inc., Princeton, NJ 08540, NDC 00781-3246-02; Carton (10 x 0.4 mL Syringes), Manufactured by Shenzhen Techdow Pharmaceutical Co., Ltd. Shenzhen City, Guangdong Province 518057, China for Sandoz Inc., Princeton, NJ 08540, NDC 00781-3246-64Temperature Abuse; temperature excursion during shippingSandoz Inc / 45,036 cartonsClass IOngoing
D-0263-202211-15-2021Carvedilol Tablets, USP, 6.25 mg, 500 Tablets bottle, Rx Only, Distributed by: Aurobindo Pharma USA Inc., 279 Princeton-Hightstown Road, East Windsor, NJ, 08520, Made in India, NDC 65862-143-05
Package NDCs: 65862-142-01; 65862-142-05; 65862-142-99; 65862-143-01; 65862-143-05; 65862-143-99; 65862-144-01; 65862-144-05; 65862-144-99; 65862-145-01; 65862-145-05; 65862-145-99
Failed Impurities/Degradation SpecificationsAurobindo Pharma USA Inc. / 7296 containersClass IIIOngoing
D-0273-202211-12-2021Allergy Relief D Fexofenadine HCl, 60 mg I Pseudoephedrine HCl, 120 mg, Extended Release Tablets, 30 Extended-Release Tablets USP, Distributed By CVS Pharmacy Inc., One CVS Drive, Woonsocket, RI 02985, Made in India, NDC 69842-249-30
Package NDCs: 69842-249-20; 69842-249-30
Failed dissolution specificationsDr. Reddy's Laboratories, Inc. / Class IIIOngoing
D-0274-202211-12-2021Allergy Relief D Fexofenadine HCl, 60 mg I Pseudoephedrine HCl, 120 mg, Extended Release Tablets, USP, 30 Extended-Release Tablets USP, Distributed By Walmart Inc., Bentonville, AR 72716, Product of India, NDC 49035-273-30.
Package NDCs: 49035-273-20; 49035-273-30
Failed dissolution specificationsDr. Reddy's Laboratories, Inc. / 9,984 cartonsClass IIIOngoing
D-0270-202211-12-2021Antihistamine & Nasal Decongestant, Fexofenadine HCl 60 mg and Pseudoephedrine HCl 120 mg, Extended Release Tablets USP, Allergy & Congestion, 12 Hour, 20 Tablets, Distributed by: Rugby Laboratories, 17177 N. Laurel Park Drive, Suite 233, Livonia, MI 48152, www.rugbylaboratories.com. NDC 0536-1242-34.
Package NDCs: 0536-1242-34; 0536-1242-07
Failed dissolution specificationsDr. Reddy's Laboratories, Inc. / 2352 cartonsClass IIIOngoing
D-0272-202211-12-202112 HR Allergy & Congestion Relief Fexofenadine HCl, 60 mg I Pseudoephedrine HCl, 120 mg Antihistamine I Nasal Decongestant, 20 Extended-Release Tablets USP, Distributed By Cardinal Health, Dublin, Ohio 43107, Made in India, NDC 70000-0518-1.
Package NDCs: 70000-0518-1; 70000-0518-2
Failed dissolution specificationsDr. Reddy's Laboratories, Inc. / 2496 cartonsClass IIIOngoing
D-0271-202211-12-2021Antihistamine & Nasal Decongestant, Fexofenadine HCl 60 mg and Pseudoephedrine HCl 120 mg, Extended Release Tablets USP, Allergy & Congestion, 12 Hour, 30 Tablets, Distributed by: Rugby Laboratories, 17177 N. Laurel Park Drive, Suite 233, Livonia, MI 48152, www.rugbylaboratories.com. NDC 0638-1242-07.Failed dissolution specificationsDr. Reddy's Laboratories, Inc. / 2184 cartonsClass IIIOngoing
D-0267-202211-12-2021Allergy & Congestion Fexofenadine HCl 60 mg & Pseudoephedrine HCl 120 mg Extended-Release Tablets, USP, 20 Extended-Release Tablets, Distributed by: Rite Aid, 30 Hunter Lane, Camp Hill, PA 17011, NDC 11822-7388-5.
Package NDCs: 11822-7388-5
Failed dissolution specificationsDr. Reddy's Laboratories, Inc. / 4896 cartonsClass IIIOngoing
D-0268-202211-12-2021Allergy & Congestion Relief Allergy Relief D, Fexofenadine HCl 60 mg/ Pseudoephedrine HCl 120 mg Extended Release Tablets, 20 extended-release tablets, Distributed by: CVS Pharmacy, Inc., One CVS Drive, Woonsocket, RI 02895, Made in India, NDC 69842-249-20
Package NDCs: 69842-249-20; 69842-249-30
Failed dissolution specificationsDr. Reddy's Laboratories, Inc. / 14976 cartonsClass IIIOngoing
D-0275-202211-12-2021Fexofenadine HCl, 60 mg & Pseudoephedrine HCl 120 mg, Extended Release Tablets USP, Allergy and Congestion, 30 Tablets, Distributed by: Dr. Reddy's Laboratories, Inc., Princeton, NJ, 08640, Made in India NDC Walmart Inc., Bentonville, AR 72716, Product of India, NDC 43598-823-31.
Package NDCs: 43598-823-14; 43598-823-31; 43598-823-35
Failed dissolution specificationsDr. Reddy's Laboratories, Inc. / 2,928 cartonsClass IIIOngoing
D-0269-202211-12-2021Fexofenadine HCl 60 mg/ Pseudoephedrine HCl 120 mg Extended Release Tablets USP Allergy & Congestion, 20 Tablets, Distributed by: Dr. Reddy's Laboratories, Inc. Princeton, NJ 08540, NDC 43598-823-14.
Package NDCs: 43598-823-14; 43598-823-31; 43598-823-35
Failed dissolution specificationsDr. Reddy's Laboratories, Inc. / 5016 cartonsClass IIIOngoing
D-0312-202211-12-2021Midazolam in 0.9% Sodium Chloride Injection, 100 mg per 100 mL (1 mg per mL), Rx only, SterRx, 141 Idaho Ave., Plattsburgh, NY 12903, NDC 70324-102-02.Lack of Assurance of SterilitySterRx, LLC / 36360 bagsClass IIOngoing
D-0314-202211-12-2021NOREPINEPHRINE in 5% Dextrose Injection, 8 mg per 250 mL (32 mg per mL) Injection, Rx only, SterRx, 141 Idaho Ave., Plattsburgh, NY 12903, NDC 70324-476-01.Lack of Assurance of SterilitySterRx, LLC / 1428 bagsClass IIOngoing
D-0325-202211-12-2021Sodium Bicarbonate in 5% Dextrose Injection, Rx Only, SterRx, 141 Idaho Ave., Plattsburgh, NY 12903, NDC 70324-326-03Lack of Assurance of SterilitySterRx, LLC / 2886 bagsClass IIOngoing
D-0310-202211-12-2021EPINEPHIrine in 0.9% Sodium Chloride Injection, 8 mg per 250 mL (32 mcg per mL), Rx only, SterRx, 141 Idaho Ave., Plattsburgh, NY 12903, NDC 70324-077-01.Lack of Assurance of SterilitySterRx, LLC / 5832 bagsClass IIOngoing
D-0306-202211-12-2021Sodium Bicarbonate in 5% Dextrose Injection, 150 mEq per 1000 mL (12.6 mg per mL), Rx only, SterRx, 141 Idaho Ave., Plattsburgh, NY 12903, NDC 70324-326-01.Lack of Assurance of SterilitySterRx, LLC / 127,260 bagsClass IIOngoing
D-0311-202211-12-2021EPINEPHrine in 0.9% Sodium Chloride Injection, 16 mg per 250 mL (64 mcg per mL), Rx only, SterRx, 141 Idaho Ave., Plattsburgh, NY 12903, NDC 70324-627-01.Lack of Assurance of SterilitySterRx, LLC / 684 bagsClass IIOngoing
D-0315-202211-12-2021dilTIAZem HCl in 5% Dextrose Injection, 125 mg per 125 mL, (32 mcg per mL), Rx only, SterRx, 141 Idaho Ave., Plattsburgh, NY 12903, NDC 70324-951-01.Lack of Assurance of SterilitySterRx, LLC / 8946 bagsClass IIOngoing
D-0324-202211-12-2021PHENYLephrine HCl, 50 mg per 250 mL, (200 mg per mL) in 0.9% Sodium Chloride Injection, Rx Only, SterRx, 141 Idaho Ave., Plattsburgh, NY 12903, NDC 70324-901-01.Lack of Assurance of SterilitySterRx, LLC / 23,136 bagsClass IIOngoing
D-0309-202211-12-2021EPINEPHIrine in 0.9% Sodium Chloride Injection, 5 mg per 250 mL (20 mcg per mL), Rx only, SterRx, 141 Idaho Ave., Plattsburgh, NY 12903, NDC 70324-052-01.Lack of Assurance of SterilitySterRx, LLC / 7548 bagsClass IIOngoing
D-0313-202211-12-2021Morphine Sulfate in 5% Dextrose Injection, 100 mg per 100 mL (1 mg per mL), Rx only, SterRx, 141 Idaho Ave., Plattsburgh, NY 12903, NDC 70324-452-01.Lack of Assurance of SterilitySterRx, LLC / 40 bagsClass IIOngoing
D-0303-202211-12-2021NOREPINEPHRINE 4 mg per 250 mL (16 mcg per mL) in 5% Dextrose Injection, Rx only, SterRx, 141 Idaho Ave., Plattsburgh, NY 12903, NDC 70324-451-01.Lack of Assurance of SterilitySterRx, LLC / 9360 bagsClass IIOngoing
D-0316-202211-12-2021Fentanyl Citrate, in 0.9% Sodium Chloride Injection, 1 mg per 100 mL, (10 mcg per mL), Rx Only, SterRx, 141 Idaho Ave., Plattsburgh, NY 12903, NDC 70324-327-01.Lack of Assurance of SterilitySterRx, LLC / 10660 bagsClass IIOngoing
D-0322-202211-12-2021NOREPINEPHRINE, 16 mg per 250 mL, (64 mcg per mL) in 0.9% Sodium Chloride Injection, SterRx, 141 Idaho Ave., Plattsburgh, NY 12903, NDC 70324-926-01.Lack of Assurance of SterilitySterRx, LLC / 36,576 bagsClass IIOngoing
D-0304-202211-12-2021EPINEPHrine, 2 mg per 250 mL (8 mcg per mL) in 0.9% Sodium Chloride Injection, Rx only, SterRx, 141 Idaho Ave., Plattsburgh, NY, 12903, NDC 70324-027-01.Lack of Assurance of SterilitySterRx, LLC / 2779 bagsClass IIOngoing
D-0318-202211-12-2021MORPHINE SULFATE, in 0.9% Sodium Chloride Injection, 50 mg per 50 mL, (1 mg per mL), Rx only, SterRx, 141 Idaho Ave., Plattsburgh, NY 12903, NDC 70324-427-01.Lack of Assurance of SterilitySterRx, LLC / 880 bagsClass IIOngoing
D-0305-202211-12-2021PHENYLepherine HCL in 0.9% Sodium Chloride, 20 mg per 250 mL (80 mcg per mL), Rx only, SterRx, 141 Idaho Avenue, Plattsburgh, NY 12903, NDC 70324-701-01.Lack of Assurance of SterilitySterRx, LLC / 18,948 bagsClass IIOngoing
D-0320-202211-12-2021NOREPINEPHRINE, 4 mg per 250 mL, (18 mcg per mL) in 0.9% Sodium Chloride Injection, Rx only, SterRx, 141 Idaho Ave., Plattsburgh, NY 12903, NDC 70324-651-01.Lack of Assurance of SterilitySterRx, LLC / 121,584 bagsClass IIOngoing
D-0317-202211-12-2021Fentanyl Citrate, in 0.9% Sodium Chloride Injection, 2.5 mg per 250 mL, (10 mcg per mL), Rx Only, SterRx, 141 Idaho Ave., Plattsburgh, NY 12903, NDC 70324-327-02.Lack of Assurance of SterilitySterRx, LLC / 5000 bagsClass IIOngoing
D-0307-202211-12-2021Succinylcholine Chloride Injection, 200 mg per 10 mL (20 mg per mL), 1,000 mL, Rx only, SterRx, 141 Idaho Avenue, Plattsburgh, NY 12903, NDC 70324-826-01.Lack of Assurance of SterilitySterRx, LLC / 3540 bagsClass IIOngoing
D-0301-202211-12-2021Morphine Sulfate in 0.9% Sodium Chloride Injection, 100 mg per 100 mL (1 mg per mL), Rx only, SterRx, 141 Idaho Avenue, Plattsburgh, NY, 12903, NDC 70324-427-02.Lack of Assurance of SterilitySterRx, LLC / 880 unitsClass IIOngoing
D-0321-202211-12-2021NOREPINEPHRINE, 8 mg per 250 mL, (32 mcg per mL) in 0.9% Sodium Chloride Injection, Rx only, SterRx, 141 Idaho Ave., Plattsburgh, NY 12903, NDC 70324-676-01.Lack of Assurance of SterilitySterRx, LLC / 74,508 bagsClass IIOngoing
D-0319-202211-12-2021NOREPINEPHRINE, 16 mg per 250 mL, (64 mcg per mL) in 5% Dextrose Injection, Rx only, SterRx, 141 Idaho Ave., Plattsburgh, NY 12903, NDC 70324-002-01.Lack of Assurance of SterilitySterRx, LLC / 1044 bagsClass IIOngoing
D-0308-202211-12-2021EPINEPHIrine in 0.9% Sodium Chloride Injection, 4 mg per 250 mL (16 mcg per mL), Rx only, SterRx, 141 Idaho Ave., Plattsburgh, NY 12903, NDC 70324-227-01.Lack of Assurance of SterilitySterRx, LLC / 26,928 bagsClass IIOngoing
D-0300-202211-12-2021Midazolam in 0.9% Sodium Chloride Injection, 50 mg per 50 mL (1 mg per mL), Rx only, SterRx, 141 Idaho Ave. Plattsburgh, NY 12003, NDC #70324-102-01.Lack of Assurance of SterilitySterRx, LLC / 15660 bagsClass IIOngoing
D-0323-202211-12-2021PHENYLephrine HCl, 40 mg per 250 mL, (160 mcg per mL) in 0.9% Sodium Chloride Injection, Rx Only, SterRx, 141 Idaho Ave., Plattsburgh, NY 12903, NDC 70324-252-01.Lack of Assurance of SterilitySterRx, LLC / 20640 bagsClass IIOngoing
D-0302-202211-12-2021dilTIAZem HCl 125 mg per 125 mL (1 mg per mL) in 0.7% Sodium Chloride Injection, Rx only, SterRx, 141 Idaho Ave., Plattsburgh, NY, 12903, NDC 70324-976-01.Lack of Assurance of SterilitySterRx, LLC / 24300 bagsClass IIOngoing
D-0287-202211-08-2021Hand Sanitizer Foam (ethyl alcohol), 62% v/v, packaged in a) 1.5 Oz. cans, NDC 53329-970-12; b) 8 Oz. (227 g) cans, NDC 53329-970-08; and c) 16 Oz. (453 g) cans, NDC 53329-970-06; Manufactured for: Medline Industries, Inc., Northfield, IL 60093.
Package NDCs: 53329-970-12; 53329-970-08; 53329-970-06
Defective Container: Customer complaints for leaking bottles and dispensing issues.Medline Industries Inc / 470,555 bottlesClass IIOngoing
D-0282-202211-08-2021Clindamycin and Benzoyl Peroxide Gel, 1%/5% 25 g jars, Rx only, Mfg by TOLMAR Inc. Fort collins, CO 80526, NDC 0781-7263-68
Package NDCs: 0781-7263-68; 0781-6514-39; 0781-7262-22; 0781-7275-43; 0781-6525-17; 0781-7274-28; 0781-7291-46; 0781-6536-21; 0781-7290-48; 0781-7287-50; 0781-7286-44
Superpotent DrugTOLMAR, Inc. / Class IIOngoing
D-0233-202211-04-2021Flocinolone Acetonide 0.01% Topical Oil, Body Oil, Rx, packaged in 4 oz. bottle, Distributed by: Amneal Pharmaceuticals Bridgewater, NJ 08807, NDC 65162-704-86
Package NDCs: 65162-704-86
Subpotent Drug: Out-of-specification assay result was obtained for Fluocinolone Acetonide.Amneal Pharmaceuticals of New York, LLC / 7,766 bottlesClass IIOngoing
D-0234-202211-04-2021Flocinolone Acetonide 0.01% Topical Oil, Scalp Oil, Rx, packaged in 4 oz. bottle, Distributed by: Amneal Pharmaceuticals Bridgewater, NJ 08807, NDC 65162-703-86
Package NDCs: 65162-703-86
Subpotent Drug: Out-of-specification assay result was obtained for Fluocinolone Acetonide.Amneal Pharmaceuticals of New York, LLC / 15,88 bottlesClass IIOngoing
D-0229-202211-03-2021Cefixime Capsules 400 mg, 50 capsules bottles, Rx Only, Manufactured by: Alken Laboratories Ltd., Mumbai - 400 013, India, Distributed by: Ascend Laboratories LLC, Parsippany, NJ, 07054 NDC 67877-584-50
Package NDCs: 67877-584-50; 67877-584-01; 67877-584-05
Failed Impurities/Degradation SpecificationsAscend Laboratories LLC / 4104 bottlesClass IIOngoing
D-0094-202211-01-2021Acetaminophen Oral Suspension, 160 mg/5 mL, packaged in 5 mL per cup (NDC Individual cup: 68094-231-59), in a) 30-count case (NDC 30-count case: 68094-231-62), and b) 100-count case (NDC 100-count case: 68094-231-61), Hospital Use Only, Pkg. Precision Dose, Inc., S. Beloit, IL 61080.
Package NDCs: 68094-030-59; 68094-030-62; 68094-330-59; 68094-330-62; 68094-330-61; 68094-231-59; 68094-231-62; 68094-231-61
cGMP Deviations: Product manufactured with contaminated raw ingredient.Precision Dose Inc. / 166,920 unit dose cupsClass IIOngoing
D-0095-202211-01-2021Acetaminophen Oral Suspension, 325 mg/10.15 mL, packaged in 10.15 mL per cup (NDC Individual cup: 68094-330-59), in a) 30-count case (NDC 30-count case: 68094-330-62), and b) 100-count case (NDC 100-count case: 68094-330-61), Hospital Use Only, Pkg. Precision Dose, Inc., S. Beloit, IL 61080.
Package NDCs: 68094-030-59; 68094-030-62; 68094-330-59; 68094-330-62; 68094-330-61; 68094-231-59; 68094-231-62; 68094-231-61
cGMP Deviations: Product manufactured with contaminated raw ingredient.Precision Dose Inc. / 151,100 unit dose cupsClass IIOngoing
D-0235-202210-28-2021Clonidine Transdermal System, USP 0.1 mg/day, 4 patches per carton, Rx only, Manufactured by: Actavis Laboratories, UT Inc., Salt Lake City, UT, Distributed by: Actavis Pharma, Inc., Parsippany, NJ NDC 0591-3508-04
Package NDCs: 0591-3508-54; 0591-3508-04; 0591-3509-54; 0591-3509-04; 0591-3510-54; 0591-3510-04
Failed Impurities/Degradation SpecificationsTeva Pharmaceuticals USA / 64,978 patchesClass IIIOngoing
D-0277-202210-28-2021VANComycin 1g added to 250mL of 0.9% Sodium Chloride (Injection for Intravenous Use Only), 260 mL per bag, Rx Only, This is a Compounded Drug, Hospital/Office Use Only, Apollo Care 3801 Mojave Ct, Suite 101, Columbia, MO 65202, NDC 71170-254-25Crystallization: Product appears to be turbid.Apollo Care / 225 bagsClass IIOngoing
D-0232-202210-27-2021Cartia XT (Diltiazem Hydrochloride Extended-Release Capsules, USP) 120 mg, Rx Only, 90 capsules, labelled as (a) Manufactured By: Teva Pharmaceuticals USA, Inc., Parsippany, NJ 07054; (b) Manufactured By: Actavis Laboratories FL. Inc, Fort Lauderdale FL. 33314 USA, Distributed by Avista Pharma Inc. Parsippany, NJ 07054 USA. NDC 62037-597-90
Package NDCs: 62037-597-90; 62037-597-05; 62037-598-90; 62037-598-05; 62037-599-90; 62037-599-05; 62037-600-90; 62037-600-05
Labelling: Incorrect Exp. DateTeva Pharmaceuticals USA / 32316 bottlesClass IIOngoing
D-0255-202210-25-2021Topiramate Tablets, USP 50 mg, 500-count bottles, Rx Only, Manufactured by: Unichem Laboratories LTD, Ind. Area. Meerut Road, Ghaziabad -201 003, India. Manufactured for: Unichem Pharmaceuticals (USA), Inc., East Brunswick, NJ 06815, NDC 29300-116-05.
Package NDCs: 29300-115-16; 29300-115-01; 29300-115-05; 29300-115-10; 29300-116-16; 29300-116-01; 29300-116-05; 29300-116-10; 29300-117-16; 29300-117-01; 29300-117-05; 29300-117-10; 29300-118-16; 29300-118-01; 29300-118-05; 29300-118-10
DiscolorationUNICHEM PHARMACEUTICALS USA INC / 1284 bottlesClass IIIOngoing
D-0231-202210-25-2021Tadalafil Tablets, USP 20 mg, 30 count bottle, Rx Only, Manufactured for: Northstar Rx LLC Memphis, TN 38141, Manufactured by: Sun Pharmaceutical Industries Limited, India, NDC # 16714-077-01
Package NDCs: 16714-074-01; 16714-074-02; 16714-075-01; 16714-076-01; 16714-077-01
Incorrect Product Formulation: An incorrect grade of Crospovidone was used to manufacture the product.SUN PHARMACEUTICAL INDUSTRIES INC / 36,786 30-count bottlesClass IIOngoing
D-0230-202210-25-2021Tadalafil Tablets, USP 5 mg, 30 count bottle, Rx Only, Manufactured for: Northstar Rx LLC Memphis, TN 38141, Manufactured by: Sun Pharmaceutical Industries Limited, India, NDC # 16714-075-01
Package NDCs: 16714-074-01; 16714-074-02; 16714-075-01; 16714-076-01; 16714-077-01
Incorrect Product Formulation: An incorrect grade of Crospovidone was used to manufacture the product.SUN PHARMACEUTICAL INDUSTRIES INC / 73,957 30-count bottlesClass IIOngoing
D-0361-202210-22-2021Pregabalin Capsules, 50 mg, 100 count bottle, Rx only, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, Manufactured by: Sun Pharmaceutical Industries Ltd., Survey No. 259/15 Dadra-396 191, (U.T. of D & NH), India, NDC 47335-687-88.
Package NDCs: 47335-686-83; 47335-686-88; 47335-686-08; 47335-686-18; 47335-687-83; 47335-687-88; 47335-687-08; 47335-687-18; 47335-688-83; 47335-688-88; 47335-688-08; 47335-688-18; 47335-689-83; 47335-689-88; 47335-689-08; 47335-689-18; 47335-690-83; 47335-690-88; 47335-690-08; 47335-690-18; 47335-691-83; 47335-691-88; 47335-691-08; 47335-691-18; 47335-692-83; 47335-692-88; 47335-692-08; 47335-692-18; 47335-693-83; 47335-693-88; 47335-693-08; 47335-693-18
Failed Tablet/Capsule Specifications: Out of Specification results for particle Size Distribution and Bulk Density of the Active Pharmaceutical Ingredient.SUN PHARMACEUTICAL INDUSTRIES INC / 696 BottlesClass IIOngoing
D-0091-202210-20-2021Gatifloxacin Ophthalmic Solution, 0.5%, 2.5 mL bottle, Rx only, Manufactured by: Lupin Limited, Pithampur (M.P.) 454 775, INDIA, NDC 68180-435-01.
Package NDCs: 68180-435-01
Failed Stability Specifications: Out-of-specification results observed in a water loss test that might affect the assay content and alter drug concentration.Lupin Pharmaceuticals Inc. / 16,272 bottlesClass IIIOngoing
D-0093-202210-19-2021Cubicin (daptomycin for injection), 500 mg per vial, Single-dose vial, Rx only. Manuf. for: Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Whitehouse Station, NJ 08889, USA. Manuf. by: Baxter Pharmaceuticals LLC., Bloomington, IN 47403, USA, NDC: 67919-011-01
Package NDCs: 67919-011-01
Presence of Particulate Matter: Identified as Glass ParticlesMERCK SHARP & DOHME CORP / 76,163 vialsClass IOngoing
D-0258-202210-19-2021Diclofenac Sodium Topical Solution USP, 1.5 w/w, 5 fl oz (150 mL) plastic bottles, Rx only, Teligent Pharma, Inc., Buena, New Jersey, 08310, NDC 52565-002-05
Package NDCs: 72275-719-77; 52565-002-05; 53329-984-16
Defective ContainerTeligent Pharma, Inc. / 2664 bottlesClass IIOngoing
D-0259-202210-19-2021Diclofenac Sodium Topical Solution USP, 1.5 w/w, 5 fl oz (150 mL) plastic bottles, Rx only, Teligent Pharma, Inc., Buena, New Jersey, 08310, NDC 70512-025-05.
Package NDCs: 70512-025-05
Defective ContainerTeligent Pharma, Inc. / 5400 unitsClass IIOngoing
D-0079-202210-18-2021Rizatriptan 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
Package NDCs: 33342-093-48; 33342-093-07; 33342-093-46; 33342-093-12; 33342-093-52; 33342-093-73; 33342-093-72; 33342-093-41; 33342-093-45; 33342-094-47; 33342-094-07; 33342-094-46; 33342-094-12; 33342-094-52; 33342-094-73; 33342-094-72; 33342-094-41; 33342-094-45
Out-of-specification test results obtained in Organic Impurities test during analysis of controlled samples.MACLEODS PHARMA USA, INC / 13,260 Blister Packs/238,680 tabletsClass IIIOngoing
D-0080-202210-18-2021Rizatriptan 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
Package NDCs: 33342-093-48; 33342-093-07; 33342-093-46; 33342-093-12; 33342-093-52; 33342-093-73; 33342-093-72; 33342-093-41; 33342-093-45; 33342-094-47; 33342-094-07; 33342-094-46; 33342-094-12; 33342-094-52; 33342-094-73; 33342-094-72; 33342-094-41; 33342-094-45
Out-of-specification test results obtained in Organic Impurities test during analysis of controlled samples.MACLEODS PHARMA USA, INC / 643,800 Blister Packs /888,336 TabletsClass IIIOngoing
D-0078-202210-18-2021Rizatriptan 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
Package NDCs: 33342-087-07; 33342-087-46; 33342-087-12; 33342-087-52; 33342-087-50; 33342-087-72; 33342-087-02; 33342-087-45; 33342-087-41; 33342-088-07; 33342-088-46; 33342-088-12; 33342-088-52; 33342-088-50; 33342-088-72; 33342-088-02; 33342-088-45; 33342-088-41
Out-of-specification test results obtained in Organic Impurities test during analysis of controlled samples.MACLEODS PHARMA USA, INC / 135,082 Blister Packs/2,431,476 tabletsClass IIIOngoing
D-0227-202210-14-2021Ezetimibe and Simvastatin Tablets, 10 mg/40mg, a) 90 Tablets, b) 500 tablets, Rx only, Manufactured by Dr. Reddy's Laboratories LA LLC Shreveport, LA 71106 USA, Packaged by GSMS, Incorporated Camarillo, CA 93012 USA; NDC: a) 51407-192-90, b) 51407-192-05
Package NDCs: 51407-190-30; 51407-190-90; 51407-190-10; 51407-191-30; 51407-191-90; 51407-191-10; 51407-192-30; 51407-192-90; 51407-192-05; 51407-192-10; 51407-193-30; 51407-193-90; 51407-193-05
Failed Excipient Specifications and Presence of Foreign Tablets/Capsules; product manufactured using an excipient found to be OOS for conductivity and some Ezetimibe and Simvastatin Tablets, 10 mg/10 mg were found in the bottleGolden State Medical Supply Inc. / a) 101 b) 145 bottlesClass IIOngoing
D-0228-202210-14-2021Ezetimibe and Simvastatin Tablets, 10 mg/80mg, 500 tablet bottles, Rx only, Manufactured by Dr. Reddy's Laboratories LA LLC Shreveport, LA 71106 USA, Packaged by GSMS, Incorporated Camarillo, CA 93012 USA; NDC 51407-193-05
Package NDCs: 51407-190-30; 51407-190-90; 51407-190-10; 51407-191-30; 51407-191-90; 51407-191-10; 51407-192-30; 51407-192-90; 51407-192-05; 51407-192-10; 51407-193-30; 51407-193-90; 51407-193-05
Failed Excipient Specification; product manufactured using an excipient found to be OOS for conductivityGolden State Medical Supply Inc. / 49Class IIOngoing
D-0074-202210-13-2021North 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 02917Failed Stability Specifications: Out-of-Specification results observed for Aspirin related compound Salicylic Acid.Ultra Seal Corporation / 250,000 tabletsClass IIIOngoing
D-0070-202210-13-2021PainAway 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)Failed Stability Specifications: Out-of-Specification results observed for Aspirin related compound Salicylic Acid.Ultra Seal Corporation / 2,484,274 tabletsClass IIIOngoing
D-0072-202210-13-2021ZEE+ 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)Failed Stability Specifications: Out-of-Specification results observed for Aspirin related compound Salicylic Acid.Ultra Seal Corporation / 1,968,150 tabletsClass IIIOngoing
D-0075-202210-13-2021Advance 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)Failed Stability Specifications: Out-of-Specification results observed for Aspirin related compound Salicylic Acid.Ultra Seal Corporation / 991,310 tabletsClass IIIOngoing
D-0071-202210-13-2021Vica-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)Failed Stability Specifications: Out-of-Specification results observed for Aspirin related compound Salicylic Acid.Ultra Seal Corporation / 1,367,525 tabletsClass IIIOngoing
D-0073-202210-13-2021AERO 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 )Failed Stability Specifications: Out-of-Specification results observed for Aspirin related compound Salicylic Acid.Ultra Seal Corporation / 1,480,981 tabletsClass IIIOngoing
D-0076-202210-13-2021Xpect 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)Failed Stability Specifications: Out-of-Specification results observed for Aspirin related compound Salicylic Acid.Ultra Seal Corporation / 42,394,018 tabletsClass IIIOngoing
D-0077-202210-13-2021Afassco 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)Failed Stability Specifications: Out-of-Specification results observed for Aspirin related compound Salicylic Acid.Ultra Seal Corporation / 519,600 tabletsClass IIIOngoing
D-0219-202210-12-2021TRI-MIX PAPAVERINE 30/PHENTOLAMINE 3/PGE-1 40 INJ INJECTABLE, Rx only, Talon Compounding Pharmacy, 2950 Thousand Oaks Drive Ste 25, San Antonio, Texas 78247Lack of assurance of sterilityVita Pharmacy, LLC dba Talon Compounding Pharmacy / 2 vialsClass IIOngoing
D-0137-202210-12-2021QUAD-MIX PAPAV 30/PHENTOL 1/PGE-1 20/ATROPINE 0.1 INJ INJECTABLE, Rx only, Talon Compounding Pharmacy, 2950 Thousand Oaks Drive Ste 25, San Antonio, Texas 78247Lack of assurance of sterilityVita Pharmacy, LLC dba Talon Compounding Pharmacy / 1 vialClass IIOngoing
D-0215-202210-12-2021TRI-MIX PAPAVERINE 30/PHENTOLAMINE 2/PGE-1 60 INJ INJECTABLE, Rx only, Talon Compounding Pharmacy, 2950 Thousand Oaks Drive Ste 25, San Antonio, Texas 78247Lack of assurance of sterilityVita Pharmacy, LLC dba Talon Compounding Pharmacy / 1 vialClass IIOngoing
D-0152-202210-12-2021TEST CYPIONATE 200MG/ANASTROZOLE 0.5MG/DUTASTERIDE 0.75MG/ML IN OIL INJECTABLE, Rx only, Talon Compounding Pharmacy, 2950 Thousand Oaks Drive Ste 25, San Antonio, Texas 78247Lack of assurance of sterilityVita Pharmacy, LLC dba Talon Compounding Pharmacy / 2 vialsClass IIOngoing
D-0168-202210-12-2021TESTOSTERONE BI-BLEND 100/100MG/ML INJECTABLE, Rx only, Talon Compounding Pharmacy, 2950 Thousand Oaks Drive Ste 25, San Antonio, Texas 78247Lack of assurance of sterilityVita Pharmacy, LLC dba Talon Compounding Pharmacy / 1 vialClass IIOngoing
D-0139-202210-12-2021QUAD-MIX PAPAV 30/PHENTOL 2/PGE-1 200/ATROPINE 0.02 INJ INJECTABLE, Rx only, Talon Compounding Pharmacy, 2950 Thousand Oaks Drive Ste 25, San Antonio, Texas 78247Lack of assurance of sterilityVita Pharmacy, LLC dba Talon Compounding Pharmacy / 1 vialClass IIOngoing
D-0150-202210-12-2021TEST CYPIONATE 200MG/ANASTROZOLE 0.25MG/DUTASTERIDE 1MG/ML IN OIL INJECTABLE, Rx only, Talon Compounding Pharmacy, 2950 Thousand Oaks Drive Ste 25, San Antonio, Texas 78247Lack of assurance of sterilityVita Pharmacy, LLC dba Talon Compounding Pharmacy / 2 vialsClass IIOngoing
D-0111-202210-12-2021ESTRADIOL VALERATE 30MG/ML INJ #1 IN ETHYL OLEATE OIL INJECTABLE, Rx only, Talon Compounding Pharmacy, 2950 Thousand Oaks Drive Ste 25, San Antonio, Texas 78247Lack of assurance of sterilityVita Pharmacy, LLC dba Talon Compounding Pharmacy / 2 vialsClass IIOngoing
D-0141-202210-12-2021QUAD-MIX PAPAV 30/PHENTOL 3/PGE-1 100/ATROPINE 0.2 INJ INJECTABLE, Rx only, Talon Compounding Pharmacy, 2950 Thousand Oaks Drive Ste 25, San Antonio, Texas 78247Lack of assurance of sterilityVita Pharmacy, LLC dba Talon Compounding Pharmacy / 2 vialsClass IIOngoing