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 11-29-2021 and include a total of 13308 recall reports.

Recall Number Initiation Date Product Description Recall Reason Recall Firm / Quantity Recall Classification Status
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-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-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-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-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-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-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-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-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-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-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-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-0068-202210-12-2021Loratadine-D Extended-Release Tablets (Loratadine and Pseudoephedrine Sulfate, Extended-Release Tablets, USP 10mg/240mg) , 10-count blister packs, Distributed By Major Pharmaceuticals, 17177 N Laurel Park Drive, Suite 233, Livonia, MI 48152, NDC 0904-5833-15
Package NDCs: 0904-5833-15; 0904-5833-48
Failed Moisture LimitsSUN PHARMACEUTICAL INDUSTRIES INC / 22,752 blister packsClass IIIOngoing
D-0069-202210-12-2021AllerClear D-24 hr, (Loratadine and Pseudoephedrine Sulfate, Extended-Release Tablets, USP 10/240mg), 15-count blister packs, Manufactured by: Ohm Laboratories Inc., 1385 Livingston Avenue, North Brunswick, NJ 08902, NDC 63981-724-15
Package NDCs: 63981-724-15
Failed Moisture LimitsSUN PHARMACEUTICAL INDUSTRIES INC / 46,584 blister packsClass IIIOngoing
D-0089-202210-12-2021Irbesartan and Hydrochlorothiazide Tablets USP, 150/12.5 mg a) 30 count (NDC 68180-413-06) and b) 90 count (NDC 68180-413-09) bottles, Rx only
Package NDCs: 68180-413-06; 68180-413-09; 68180-414-06; 68180-414-09
CGMP Deviations: impurity N-nitrosoirbesartan detected in APILupin Pharmaceuticals Inc. / 63,408 bottlesClass IIOngoing
D-0126-202210-12-2021METHYLCOBALAMIN 5MG/ML (5000MCG/ML) INJ 5MG/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-0090-202210-12-2021Irbesartan and Hydrochlorothiazide Tablets USP, 300/12.5 mg a) 30 count (NDC 68180-414-06) and b) 90 count (NDC 68180-414-09) bottles, Rx only
Package NDCs: 68180-413-06; 68180-413-09; 68180-414-06; 68180-414-09
CGMP Deviations: impurity N-nitrosoirbesartan detected in APILupin Pharmaceuticals Inc. / 98,052 bottlesClass IIOngoing
D-0087-202210-12-2021Irbesartan Tablets USP, 150 mg a) 30 count (NDC 68180-411-06) and b) 90 count (NDC 68180-411-09) bottles, Rx only
Package NDCs: 68180-410-06; 68180-410-09; 68180-411-06; 68180-411-02; 68180-411-09; 68180-412-06; 68180-412-02; 68180-412-09
CGMP Deviations: impurity N-nitrosoirbesartan detected in APILupin Pharmaceuticals Inc. / 134,016 bottlesClass IIOngoing
D-0208-202210-12-2021TRI-MIX PAPAVERINE 30/PHENTOLAMINE 1/PGE-1 30 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 / 5 vialsClass IIOngoing
D-0205-202210-12-2021TRI-MIX PAPAVERINE 30/PHENTOLAMINE 1/PGE-1 2.5 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 / 30 vialsClass IIOngoing
D-0154-202210-12-2021TEST CYPIONATE 200MG/ANASTROZOLE 0.5MG/DUTASTERIDE 1MG/ML #2 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 / 4 vialsClass IIOngoing
D-0173-202210-12-2021TESTOSTERONE CYPIONATE 200MG/ANASTROZOLE 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 / 4 vialsClass IIOngoing
D-0214-202210-12-2021TRI-MIX PAPAVERINE 30/PHENTOLAMINE 2/PGE-1 50 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 / 4 vialsClass IIOngoing
D-0121-202210-12-2021IVME SUPER B 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 / 99 vialsClass IIOngoing
D-0181-202210-12-2021TESTOSTERONE CYPIONATE 20MG/ML INJ #1 IN ETHYL OLEATE 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 / 7 vialsClass IIOngoing
D-0105-202210-12-2021ALPROSTADIL 45MCG/ML 45MCG/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 / 2 vialsClass IIOngoing
D-0128-202210-12-2021MIC 20/40/50 /B COMPLEX +CHROM/CARN 25/25MG/ML+LIDO 20/40/50/25/25MG/ML+LIDO 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-0202-202210-12-2021TRI-MIX PAPAVERINE 30/PHENTOLAMINE 0.5/PGE-1 40 /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-0086-202210-12-2021Irbesartan Tablets USP, 75 mg a) 30 count (NDC 68180-410-06) and b) 90 count (NDC 68180-410-09) bottles, Rx only
Package NDCs: 68180-410-06; 68180-410-09; 68180-411-06; 68180-411-02; 68180-411-09; 68180-412-06; 68180-412-02; 68180-412-09
CGMP Deviations: impurity N-nitrosoirbesartan detected in APILupin Pharmaceuticals Inc. / 51,144 bottlesClass IIOngoing
D-0196-202210-12-2021TRI-MIX PAPAVERINE 25MG/PHENTOLAMINE 1MG/PGE1 25MCG/ML 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-0116-202210-12-2021GOAL-GLUTAMINE 75MG/ORNITHINE 75MG/ARGININE 150MG/LYSINE 150MG+LIDOCAINE 10MG/ML 75MG/75MG/150MG/150MG/10MG/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 / 5 vialsClass IIOngoing
D-0088-202210-12-2021Irbesartan Tablets USP, 300 mg a) 30 count (NDC 68180-412-06) and b) 90 count NDC# 68180-412-09) bottles, Rx only
Package NDCs: 68180-410-06; 68180-410-09; 68180-411-06; 68180-411-02; 68180-411-09; 68180-412-06; 68180-412-02; 68180-412-09
CGMP Deviations: impurity N-nitrosoirbesartan detected in APILupin Pharmaceuticals Inc. / 119,544 bottlesClass IIOngoing
D-0122-202210-12-2021L-CARNITINE 250MG/ML 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 / 4 vialsClass 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-0194-202210-12-2021TRI-MIX PAPAVERINE 23.3/PHENTOLAMINE 1/PGE-1 12 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-0107-202210-12-2021BI-MIX PAPAVERINE 40/PHENTOLAMINE 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 / 1 vialClass IIOngoing
D-0188-202210-12-2021TRI-MIX PAPAVERINE 15/PHENTOLAMINE 1/PGE-1 10 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-0099-202210-12-2021ALPROSTADIL 22.5MCG/ML 22.5MCG/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-0092-202210-12-2021Methocarbamol 500mg Tablet, packaged in a) #30 count (NDC 7133517952), b) #60 count (NDC 7133517954), and c) #90 count (NDC 7133517957) bottles, Rx only, Prinston Laboratories, Packaged by Bryant Ranch Prepack Burbank, CA 91504Labeling: Label Error on Declared Strength; Bottles labeled as Methocarbamol 500 mg Tablets actually contain Methocarbamol 750 mg TabletsBryant Ranch Prepack, Inc. dba BRP Pharmaceuticals / a) 124, b) 29, c) 73Class IOngoing
D-0189-202210-12-2021TRI-MIX PAPAVERINE 15/PHENTOLAMINE 2/PGE-1 20 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-0195-202210-12-2021TRI-MIX PAPAVERINE 25/PHENTOLAMINE 3/PGE-1 80 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-0106-202210-12-2021B COMPLEX INJ CMP-NO B12, NO LIDOCAINE 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-0135-202210-12-2021QUAD-MIX PAPAV 20/PHENTOL 2/PGE-1 25/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 / 4 vialsClass IIOngoing
D-0164-202210-12-2021TEST CYPIONATE 200MG/ANASTROZOLE 2MG/DUTASTERIDE 2MG/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-0191-202210-12-2021TRI-MIX PAPAVERINE 18/PHENTOL 0.6/PGE-1 5.88/ML 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-0158-202210-12-2021TEST CYPIONATE 200MG/ANASTROZOLE 1.5MG/DUTASTERIDE 2MG/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-0098-202210-12-2021(WELL'S LIPO-LEAN)INOSITOL/CHOLINE/B-COMP+LEUCINE+CARN+ CHROM+LIDO 25MG/25MG/1.5MG/25MG/25MCG/10MG INJECTABLE in vials, 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-0131-202210-12-2021MIC B COMPLEX WITH HYDROXOCOBALAMIN 5MG/ML 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 / 6 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-0160-202210-12-2021TEST CYPIONATE 200MG/ANASTROZOLE 1MG/DUTASTERIDE 1.5MG/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 / 1 vialClass IIOngoing
D-0165-202210-12-2021TEST CYPIONATE 200MG/DUTASTERIDE 0.5MG/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 / 21 vialsClass IIOngoing
D-0148-202210-12-2021ULTRA-TEST (CYP 80%/PROP 20%) 200MG/ML INJ #1 200MG/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 / 23 vialsClass IIOngoing
D-0193-202210-12-2021TRI-MIX PAPAVERINE 20/PHENTOLAMINE 1/PGE-1 20 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-0118-202210-12-2021HYDROXOCOBALAMIN 5,000MCG/ML INJ 5,000MCG/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-0115-202210-12-2021ESTRADIOL VALERATE 5MG/ML IN ETHYL OLEATE 5MG/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 / 7 vialsClass IIOngoing
D-0206-202210-12-2021TRI-MIX PAPAVERINE 30/PHENTOLAMINE 1/PGE-1 20 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 / 22 vialsClass 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-0166-202210-12-2021TEST CYPIONATE 200MG/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 / 6 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-0127-202210-12-2021MIC 20/40/50 /B COMPLEX +CHROM/CARN 25/25MG/ML 20/40/50/25/25MG/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-0142-202210-12-2021QUAD-MIX PAPAV 30/PHENTOL 4/PGE-1 40/ATROPINE 0.4 INJ *C6* 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-0217-202210-12-2021TRI-MIX PAPAVERINE 30/PHENTOLAMINE 3/PGE-1 30 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 / 3 vialsClass IIOngoing
D-0167-202210-12-2021TEST CYPIONATE 200MG/DUTASTERIDE 2MG/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-0187-202210-12-2021TRI-MIX PAPAVERINE 15/PHENTOLAMINE 0.5/PGE-1 5 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-0184-202210-12-2021TESTOSTERONE CYPIONATE 50MG/ML INJ #1 IN ETHYL OLEATE 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 / 40 vialsClass IIOngoing
D-0213-202210-12-2021TRI-MIX PAPAVERINE 30/PHENTOLAMINE 2/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 / 8 vialsClass IIOngoing
D-0212-202210-12-2021TRI-MIX PAPAVERINE 30/PHENTOLAMINE 2/PGE-1 30 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 / 7 vialsClass IIOngoing
D-0175-202210-12-2021TESTOSTERONE CYPIONATE 200MG/ANASTROZOLE 1.5MG/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 / 6 vialsClass IIOngoing
D-0101-202210-12-2021ALPROSTADIL 25MCG/ML 25MCG/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 / 3 vialsClass 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-0225-202210-12-2021TRI-MIX PAPAVERINE 40/PHENTOLAMINE 2/PGE-1 10 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-0185-202210-12-2021TRI-MIX PAPAV 23.3MG/PHENTOL 1MG/PGE-1 12MCG/ML 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-0157-202210-12-2021TEST CYPIONATE 200MG/ANASTROZOLE 1.5MG/DUTASTERIDE 1.5MG/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-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-0145-202210-12-2021SERMORELIN ACETATE 9MG/IPAMORELIN 9MG - LYOPHILIZED 9MG/9MG VIAL, 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 / 3 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
D-0169-202210-12-2021TESTOSTERONE CYPIONATE 100MG/ML INJ #1 IN ETHYL OLEATE 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 / 168 vialsClass IIOngoing
D-0123-202210-12-2021LEUCINE 10MG/ ISOLEUCINE 15MG/ VALINE 40MG/ML (BCAA) INJ 10MG/15MG/40MG/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 / 5 vialsClass IIOngoing
D-0222-202210-12-2021TRI-MIX PAPAVERINE 30/PHENTOLAMINE 4/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 / 3 vialsClass 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-0125-202210-12-2021METHYLCOBALAMIN 1MG/ML (1000MCG/ML) INJ 1MG/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 / 324 vialsClass IIOngoing
D-0177-202210-12-2021TESTOSTERONE CYPIONATE 200MG/ANASTROZOLE 1MG/ML #2 IN SESAME 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 / 6 vialsClass IIOngoing
D-0197-202210-12-2021TRI-MIX PAPAVERINE 26/PHENTOLAMINE 3/PGE-1 60/ML 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-0163-202210-12-2021TEST CYPIONATE 200MG/ANASTROZOLE 2MG/DUTASTERIDE 0.5MG/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 / 4 vialsClass IIOngoing
D-0112-202210-12-2021ESTRADIOL VALERATE 40MG/ML IN ETHYL OLEATE 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 / 11 vialsClass IIOngoing
D-0120-202210-12-2021IVME HCG VITAMIN B INJ (CONTAINS NO HCG) 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 / 122 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-0218-202210-12-2021TRI-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-0190-202210-12-2021TRI-MIX PAPAVERINE 17.65/PHENTOLAMINE 0.59/PGE-1 5.9 INJ **T 101** 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