FDA Recall
TerminatedTerminated: December 2, 2015Historical recordClass III
Lamivudine Oral Solution, USP, 10 mg per 1 mL, 240 mL bottle (8 ounces), Rx only, Manufactured by: Silarx Pharmaceuticals, Inc. Carmel, NY 10512, NDC 54838-0566-70
by Silarx Pharmaceutical, Inc.
- Reason
- Labeling: Incorrect or Missing Lot and/or Exp. Date - Firm received a customer complaint that the expiration date printed on the unit carton (5/18) does not match the expiration date on the bottle label (5/17).
- Published
- September 9, 2015
- Distribution
- Nationwide
View recall →
FDA Recall
TerminatedTerminated: May 31, 2016Historical recordClass II
Bi-Est (estriol,estradiol), Progesterone Vaginal Suppository, Rx only, Manufactured by Park Compounding, Irvine, CA
by South Coast Specialty Compounding, Inc.
- Reason
- Penicillin Cross Contamination: Multiple finished products potentially contaminated with penicillin.
- Published
- September 9, 2015
- Distribution
- Nationwide
View recall →
FDA Recall
TerminatedTerminated: May 31, 2016Historical recordClass II
Bi-Est (estriol,estradiol), Progesterone, Testosterone cream, Rx only, Manufactured by Park Compounding, Irvine, CA
by South Coast Specialty Compounding, Inc.
- Reason
- Penicillin Cross Contamination: Multiple finished products potentially contaminated with penicillin.
- Published
- September 9, 2015
- Distribution
- Nationwide
View recall →
FDA Recall
TerminatedTerminated: May 31, 2016Historical recordClass II
Estradiol cream, Rx only, Manufactured by Park Compounding, Irvine, CA
by South Coast Specialty Compounding, Inc.
- Reason
- Penicillin Cross Contamination: Multiple finished products potentially contaminated with penicillin.
- Published
- September 9, 2015
- Distribution
- Nationwide
View recall →
FDA Recall
TerminatedTerminated: May 31, 2016Historical recordClass II
Bi-Est (estriol,estradiol) Testosterone cream, Rx only, Manufactured by Park Compounding, Irvine, CA
by South Coast Specialty Compounding, Inc.
- Reason
- Penicillin Cross Contamination: Multiple finished products potentially contaminated with penicillin.
- Published
- September 9, 2015
- Distribution
- Nationwide
View recall →
FDA Recall
TerminatedTerminated: May 31, 2016Historical recordClass II
Estriol,Estradiol cream, Rx only, Manufactured by Park Compounding, Irvine, CA
by South Coast Specialty Compounding, Inc.
- Reason
- Penicillin Cross Contamination: Multiple finished products potentially contaminated with penicillin.
- Published
- September 9, 2015
- Distribution
- Nationwide
View recall →
FDA Recall
TerminatedTerminated: May 31, 2016Historical recordClass II
Bi-Est (estriol,estradiol), Progesterone, DHEA, Testosterone drops, Rx only, Manufactured by Park Compounding, Irvine, CA
by South Coast Specialty Compounding, Inc.
- Reason
- Penicillin Cross Contamination: Multiple finished products potentially contaminated with penicillin.
- Published
- September 9, 2015
- Distribution
- Nationwide
View recall →
FDA Recall
TerminatedTerminated: May 31, 2016Historical recordClass II
Estradiol, Estriol capsules, Rx only, Manufactured by Park Compounding, Irvine, CA
by South Coast Specialty Compounding, Inc.
- Reason
- Penicillin Cross Contamination: Multiple finished products potentially contaminated with penicillin.
- Published
- September 9, 2015
- Distribution
- Nationwide
View recall →
FDA Recall
TerminatedTerminated: May 31, 2016Historical recordClass II
Estradiol, Estriol, Progesterone capsules, Rx only, Manufactured by Park Compounding, Irvine, CA
by South Coast Specialty Compounding, Inc.
- Reason
- Penicillin Cross Contamination: Multiple finished products potentially contaminated with penicillin.
- Published
- September 9, 2015
- Distribution
- Nationwide
View recall →
FDA Recall
TerminatedTerminated: May 31, 2016Historical recordClass II
Tri-Est 80:10:10 Progesterone (estriol, estradiol, estrone, progesterone) capsules Rx only, Manufactured by Park Compounding, Irvine, CA
by South Coast Specialty Compounding, Inc.
- Reason
- Penicillin Cross Contamination: Multiple finished products potentially contaminated with penicillin.
- Published
- September 9, 2015
- Distribution
- Nationwide
View recall →
FDA Recall
TerminatedTerminated: March 29, 2016Historical recordClass II
Lisinopril Tablets, USP, 40 mg, a) 45-count bottle (NDC 0603-4214-60), b) 500-count bottle (NDC 0603-4214-28), Rx Only, Manufactured for: Qualitest Pharmaceuticals, Huntsville, AL 35811
by Vintage Pharmaceuticals LLC dba Qualitest Pharmaceuticals
- Reason
- Failed Dissolution Specifications
- Published
- September 9, 2015
- Distribution
- Nationwide
View recall →
FDA Recall
TerminatedTerminated: March 7, 2016Historical recordClass III
ALLOPURINOL TABLETS, USP, 300 mg, 500 count bottle, Rx only, Manufactured for: QUALITEST PHARMACEUTICALS, HUNTSVILLE, AL 35811 --- NDC 0603-2116-28
by Qualitest Pharmaceuticals
- Reason
- Failed Tablet/Capsule Specifications; report of oversized and discolored tablets
- Published
- September 9, 2015
- Distribution
- Nationwide
View recall →
FDA Recall
TerminatedTerminated: May 31, 2016Historical recordClass II
Methyl Folate Lyophilized Powder for Injection, 20 mg per vial, Rx Only, Manufactured by Park Compounding, Irving, CA
by South Coast Specialty Compounding, Inc.
- Reason
- Penicillin Cross Contamination: Multiple finished products potentially contaminated with penicillin.
- Published
- September 9, 2015
- Distribution
- Nationwide
View recall →
FDA Recall
TerminatedTerminated: May 31, 2016Historical recordClass II
Chorionic Gonadotropin/ Hydroxocobalamin Lyophilized Powder Injectable, 10,000 UNITS/ 5000 mcg per vial, Rx Only, Manufactured by Park Compounding, Irving, CA
by South Coast Specialty Compounding, Inc.
- Reason
- Penicillin Cross Contamination: Multiple finished products potentially contaminated with penicillin.
- Published
- September 9, 2015
- Distribution
- Nationwide
View recall →
FDA Recall
TerminatedTerminated: May 31, 2016Historical recordClass II
Artesunate Lyophilized Powder for Injection, 60 mg per vial, Rx only, Manufactured by Park Compounding, Irvine, CA
by South Coast Specialty Compounding, Inc.
- Reason
- Penicillin Cross Contamination: Multiple finished products potentially contaminated with penicillin.
- Published
- September 9, 2015
- Distribution
- Nationwide
View recall →
FDA Recall
TerminatedTerminated: May 31, 2016Historical recordClass II
Meloxicam capsules, 12 mg, Rx Only, Manufactured by Park Compounding, Irving, CA -non-sterile formulation
by South Coast Specialty Compounding, Inc.
- Reason
- Penicillin Cross Contamination: Multiple finished products potentially contaminated with penicillin.
- Published
- September 9, 2015
- Distribution
- Nationwide
View recall →
FDA Recall
TerminatedTerminated: May 31, 2016Historical recordClass II
Leucovorin Calcium capsules, 10 mg, Rx only, Manufactured by Park Compounding, Irvine, CA
by South Coast Specialty Compounding, Inc.
- Reason
- Penicillin Cross Contamination: Multiple finished products potentially contaminated with penicillin.
- Published
- September 9, 2015
- Distribution
- Nationwide
View recall →
FDA Recall
TerminatedTerminated: May 31, 2016Historical recordClass II
Bi-Est 80:20 Progesterone (estriol,estradiol, progesterone) capsules, Rx only, Manufactured by Park Compounding, Irvine, CA
by South Coast Specialty Compounding, Inc.
- Reason
- Penicillin Cross Contamination: Multiple finished products potentially contaminated with penicillin.
- Published
- September 9, 2015
- Distribution
- Nationwide
View recall →
FDA Recall
TerminatedTerminated: April 23, 2018Historical recordClass II
Methylcobalamin 1,000 mcg/mL Injectable, 1.5 mL vial, Rx only, Liberty Drug Compound Center, 195 Main St., PO Box 267, Chatham, NJ 07928.
by Liberty Drug & Surgical
- Reason
- Lack of Assurance of Sterility: Process deficiencies were observed in the sterile ophthalmic and injectable products that could have compromised the sterility of the product.
- Published
- September 2, 2015
- Distribution
- Physicians, Medical Facilities, and Pres…
View recall →
FDA Recall
TerminatedTerminated: April 23, 2018Historical recordClass II
Lidocaine/Sodium Chloride 0.4%/20% Injectable, 5 mL vial, Rx only, Liberty Drug Compound Center, 195 Main St., PO Box 267, Chatham, NJ 07928.
by Liberty Drug & Surgical
- Reason
- Lack of Assurance of Sterility: Process deficiencies were observed in the sterile ophthalmic and injectable products that could have compromised the sterility of the product.
- Published
- September 2, 2015
- Distribution
- Physicians, Medical Facilities, and Pres…
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.
Read the full medical disclaimer.