FDA Recall
TerminatedTerminated: July 2, 2014Historical recordClass II
Papaverine HCl 30 mg, Phentolamine Mesylate 1 mg, a) 5 mL and b) 10 mL, JOHN HOLLIS Pharmacist, Inc 110 20th Avenue N, Nashville, TN 37203, 615-327-3234
by John W Hollis Inc
- Reason
- Lack of Assurance of Sterility: Lack of sterility assurance in compounded aseptically filled injectable products.
- Published
- June 25, 2014
- Distribution
- Nationwide
View recall →
FDA Recall
TerminatedTerminated: July 2, 2014Historical recordClass II
B-Complex/Adenosine Inj sol, Adenosine-5-Monophosphate 0.03g, Choline Chloride 0.01g, Cyanocobalamin 0.3mg, Inositol 0.05g, Methionine 0.015g, Levocarnitine 0.1g, Chromic Chloride 0.15g, Lidocaine HCl 0.01g, Pyrodoxine HCl 0.005g, 30 mL, JOHN HOLLIS Pharmacist, Inc, 110 20th Avenue N, Nashville, TN 37203, 615-327-3234
by John W Hollis Inc
- Reason
- Lack of Assurance of Sterility: Lack of sterility assurance in compounded aseptically filled injectable products.
- Published
- June 25, 2014
- Distribution
- Nationwide
View recall →
FDA Recall
TerminatedTerminated: July 2, 2014Historical recordClass II
Papaverine HCl 30 mg, Phentolamine Mesylate 1 mg, Alprostadil 20 mcg, a) 5 mL and b) 10 mL, JOHN HOLLIS Pharmacist, Inc, 110 20th Avenue N, Nashville, TN 37203, 615-327-3234
by John W Hollis Inc
- Reason
- Lack of Assurance of Sterility: Lack of sterility assurance in compounded aseptically filled injectable products.
- Published
- June 25, 2014
- Distribution
- Nationwide
View recall →
FDA Recall
TerminatedTerminated: July 2, 2014Historical recordClass II
METHYLCOBALAMIN FOR INTRAMUSCULAR OR SUBCUTANEOUS USE ONLY, Methylcobalamin 1000 mcg, Also Contains: Benzyl Alcohol, Sodium Chloride, Water, Hydrochloric Acid, and/or Sodium Hydroxide, 30 mL, JOHN HOLLIS Pharmacist, Inc. 110 20th Avenue N, Nashville, TN 37203, 615-327-3234
by John W Hollis Inc
- Reason
- Lack of Assurance of Sterility: Lack of sterility assurance in compounded aseptically filled injectable products.
- Published
- June 25, 2014
- Distribution
- Nationwide
View recall →
FDA Recall
TerminatedTerminated: July 2, 2014Historical recordClass II
Levocarnitine Solution for injection, l-Carnitine 50 mg, Also Contains Sterile Water for Injection and Benzyl Alcohol pH adjusted with HCl, 50 mL, JOHN HOLLIS Pharmacist, Inc. 110 20th Avenue N, Nashville, TN 37203, 615-327-3234
by John W Hollis Inc
- Reason
- Lack of Assurance of Sterility: Lack of sterility assurance in compounded aseptically filled injectable products.
- Published
- June 25, 2014
- Distribution
- Nationwide
View recall →
FDA Recall
TerminatedTerminated: July 2, 2014Historical recordClass II
MIC PLUS B12, Adenosine, L-Carnitine, Contains: Methionine 15mg, Choline 100mg, Inositol 50mg, B 12, 0.200mg, Adenosine 20mg, L-Carnitine 30mg/ML, 30ML MULTI DOSE VIAL, BENZYL ALCOHOL AS A PRESERVATIVE, JOHN HOLLIS Pharmacist, Inc, 110 20th Avenue N, Nashville, TN 37203, 615-327-3234
by John W Hollis Inc
- Reason
- Lack of Assurance of Sterility: Lack of sterility assurance in compounded aseptically filled injectable products.
- Published
- June 25, 2014
- Distribution
- Nationwide
View recall →
FDA Recall
TerminatedTerminated: July 2, 2014Historical recordClass II
Testosterone Cypionate for Injection, each mL contains Testosterone Cypionate 200 mg, also contains: Cotton Seed Oil, Benzyl Benzoate, Benzyl Alcohol, Rx Only, 10 mL, JOHN HOLLIS Pharmacist, Inc. 110 20th Avenue N, Nashville, TN 37203, 615-327-3234
by John W Hollis Inc
- Reason
- Lack of Assurance of Sterility: Lack of sterility assurance in compounded aseptically filled injectable products.
- Published
- June 25, 2014
- Distribution
- Nationwide
View recall →
FDA Recall
TerminatedTerminated: July 2, 2014Historical recordClass II
Polidocanol 5% Solution for Injection, each mL contains Polidocanol (Laureth 9) 50 mg, also contains Sterile Water for Injection, Ethyl Alcohol, Anhydrous Chlorobutanol, 50 mL Vial, JOHN HOLLIS Pharmacist Inc, Inc. 110 20th Avenue N, Nashville, TN 37203, 615-327-3234
by John W Hollis Inc
- Reason
- Lack of Assurance of Sterility: Lack of sterility assurance in compounded aseptically filled injectable products.
- Published
- June 25, 2014
- Distribution
- Nationwide
View recall →
FDA Recall
TerminatedTerminated: July 2, 2014Historical recordClass II
CYANOCOBALAMIN FOR INTRAMUSCULAR OR SUBCUTANEOUS USE ONLY, Each mL contains: Cyanocobalamin 1000 mcg, , Also Contains: Benzyl Alcohol, Sodium Chloride, Water, Hydrochloric Acid, and/or Sodium Hydroxide, 30 mL, JOHN HOLLIS Pharmacist Inc, 110 20th Avenue N, Nashville, TN 37203, 615-327-3234
by John W Hollis Inc
- Reason
- Lack of Assurance of Sterility: Lack of sterility assurance in compounded aseptically filled injectable products.
- Published
- June 25, 2014
- Distribution
- Nationwide
View recall →
FDA Recall
TerminatedTerminated: July 2, 2014Historical recordClass II
Liver Derivative Complex for injection, each mL contains: Liver Derivative Complex 25.5mg, also contains: Water for Injection, Phenol 0.5%, HCl or NaOH to adjust pH, 10 mL, Compounded by Prescription: JOHN HOLLIS Pharmacist Inc, 110 20th Avenue N, Nashville, TN 37203, 615-327-3234
by John W Hollis Inc
- Reason
- Lack of Assurance of Sterility: Lack of sterility assurance in compounded aseptically filled injectable products.
- Published
- June 25, 2014
- Distribution
- Nationwide
View recall →
FDA Recall
TerminatedTerminated: February 12, 2015Historical recordClass III
Foradil Aerolizer (formoterol fumarate inhalation powder), 12 mcg per capsule, 60 Capsules, Rx only, Manufactured for: Merck, Sharpe & Dohne Corp., a subsidiary of Merck & Co., Inc. Whitehouse Station, NJ 08889, Manufactured by: Novartis Pharma AG Basle, Switzerland NDC 0085-1401-01
by Novartis Pharmaceuticals Corp.
- Reason
- Failed Stability Specification; out of specification result for particle size distribution during stability testing
- Published
- June 25, 2014
- Distribution
- Nationwide
View recall →
FDA Recall
TerminatedTerminated: October 15, 2014Historical recordClass II
Captomer-250 [succinic acid (from 250 mg DMSA)] capsules, 162 mg, 45-count bottles, Manufactured By: Thorne Research, Inc., P.O. Box 25, Dover, Idaho 83825, UPC 6 93749 73502 1
by Thorne Research Inc
- Reason
- Marketed Without An Approved NDA/ANDA: Captomer and Captomer-250 are marketed as dietary supplements and labeled to be sourced from Dimercaptosuccinic Acid (DMSA) which is the active ingredient in an FDA approved drug making these products unapproved new drugs.
- Published
- June 25, 2014
- Distribution
- Nationwide
View recall →
FDA Recall
TerminatedTerminated: October 15, 2014Historical recordClass II
Captomer [succinic acid (from 100 mg DMSA)] capsules, 65 mg, 45-count bottles, Manufactured By: Thorne Research, Inc., P.O. Box 25, Dover, Idaho 83825, UPC 6 93749 74002 5
by Thorne Research Inc
- Reason
- Marketed Without An Approved NDA/ANDA: Captomer and Captomer-250 are marketed as dietary supplements and labeled to be sourced from Dimercaptosuccinic Acid (DMSA) which is the active ingredient in an FDA approved drug making these products unapproved new drugs.
- Published
- June 25, 2014
- Distribution
- Nationwide
View recall →
FDA Recall
TerminatedTerminated: July 2, 2014Historical recordClass II
Polidocanol 1% Solution for Injection, each mL contains Polidocanol (Laureth 9) 10 mg, also contains Sterile Water for Injection, Ethyl Alcohol, Anhydrous Chlorobutanol, 50 mL, JOHN HOLLIS Pharmacist, Inc. 110 B2 Avenue N, Nashville, TN 37203, 615-327-3234
by John W Hollis Inc
- Reason
- Lack of Assurance of Sterility: Lack of sterility assurance in compounded aseptically filled injectable products.
- Published
- June 25, 2014
- Distribution
- Nationwide
View recall →
FDA Recall
TerminatedTerminated: July 2, 2014Historical recordClass II
Papaverine HCl 30 mg, Phentolamine Mesylate 2 mg, Alprostadil 40 mcg, a) 5 mL and b) 10 mL, JOHN HOLLIS Pharmacist, Inc, 110 20th Avenue N, Nashville, TN 37203, 615-327-3234
by John W Hollis Inc
- Reason
- Lack of Assurance of Sterility: Lack of sterility assurance in compounded aseptically filled injectable products.
- Published
- June 25, 2014
- Distribution
- Nationwide
View recall →
FDA Recall
TerminatedTerminated: July 2, 2014Historical recordClass II
Mannitol 5% Solution for injection, Mannitol 50 mg, also contains Sterile Water for Injection, Chlorobutanol USP, 50 mL, JOHN HOLLIS Pharmacist, Inc. 110 20th Avenue N, Nashville, TN 37203, 615-327-3234
by John W Hollis Inc
- Reason
- Lack of Assurance of Sterility: Lack of sterility assurance in compounded aseptically filled injectable products.
- Published
- June 25, 2014
- Distribution
- Nationwide
View recall →
FDA Recall
TerminatedTerminated: July 2, 2014Historical recordClass II
Polidocanol 0.5% Solution for Injection, Polidocanol (Laureth 9) 5mg, 50 mL, JOHN HOLLIS Pharmacist Inc, 110 20th Avenue N, Nashville, TN 37203, 615-327-3234
by John W Hollis Inc
- Reason
- Lack of Assurance of Sterility: Lack of sterility assurance in compounded aseptically filled injectable products.
- Published
- June 25, 2014
- Distribution
- Nationwide
View recall →
FDA Recall
TerminatedTerminated: February 23, 2015Historical recordClass II
Vancomycin Hydrochloride Capsules, USP, 250 mg. 20 Capsules on 2 x 10 Capsule Blister Cards, Rx Only. Mfd. for: Watson Pharma Inc., Parsippany, NJ 07054 USA. Mfd. by: Patheon Pharmaceuticals Inc., Cincinnati, OH 45237 USA. NDC 0591-3561-15.
by Actavis Inc
- Reason
- Subpotent Drug.
- Published
- June 25, 2014
- Distribution
- Nationwide
View recall →
FDA Recall
TerminatedTerminated: July 22, 2016Historical recordClass I
CUBICIN (daptomycin for injection), 500 mg single-use vial, Rx only, Manufactured for: Cubist Pharmaceuticals, Inc., Lexington, MA 02421, NDC 67919-011-01, UPC 3 67919-011-01 6.
by Cubist Pharmaceuticals, Inc.
- Reason
- Presence of Particulate Matter: Customer complaint stating that one vial contained a glass shard.
- Published
- June 18, 2014
- Distribution
- Nationwide
View recall →
FDA Recall
TerminatedTerminated: May 1, 2015Historical recordClass II
Dr. Reddy's Metoprolol Succinate Extended Release Tablets, USP 25 mg. 100-count bottle, Rx only, Manufactured By: Dr. Reddy's Laboratories Limited, Batchupally - 500 090 India. NDC55111-466-01
by Dr. Reddy's Laboratories, Inc.
- Reason
- Failed Dissolution Specifications: Failure of dissolution test observed at the 18 month time point.
- Published
- June 18, 2014
- 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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