Recall archive
10 recalls · page 1 of 1
Reported Nov 1, 2017
Enalapril Maleate tablets, USP, 5mg, 1000-count bottles, Rx only, Manufactured by: Wockhardt Limited H-14/2, M.I.D.C.…
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.Wockhardt USA Inc.
Matched: Brand · Product · Product details — Failed Impurities/Degradation Specifications: 5mg strength being recalled for out of specification results for related compound.
FDA (openFDA drug enforcement)
Reported Aug 26, 2015
Lisinopril Tablets USP, 5 mg, 1000-count bottles, Rx Only, Manufactured by: Wockhardt Limited, Mumbai, India;…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Wockhardt USA Inc.
Matched: Brand · Product · Product details — CGMP Deviations: An FDA inspection identified inadequate investigations of past market complaints.
1 more product in this recall
FDA (openFDA drug enforcement)
Reported Jul 29, 2015
Amlodipine Besylate Tablets, 2.5 mg Tablets, Packaged in 90 Count Bottles, Rx Only. Manufactured by: Wockhardt Limited,…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Wockhardt USA Inc.
Matched: Brand · Product · Product details — CGMP Deviations: Firm did not adequately investigate customer complaints.
34 more products in this recall
FDA (openFDA drug enforcement)
Reported May 13, 2015
Captopril Tablets, USP 12.5 mg, Rx Only, a) 100 count bottles NDC 64679-902-01, b) 1000 count bottles NDC 64679-902-02,…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Wockhardt USA Inc.
Matched: Brand · Product details — Failed Tablet/Capsule Specifications: out of specification for thickness.
FDA (openFDA drug enforcement)
Reported Dec 24, 2014
Wockhardt Metoprolol Succinate, Extended-Release Tablets USP, 50 mg, a)100-count HDPE bottle (NDC 64679-735-02), b)…
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.Wockhardt USA Inc.
Matched: Brand · Product · Product details — Failed Dissolution Specifications: Product was out of specification (OOS) at the 12 month long term stability testing point.
FDA (openFDA drug enforcement)
Reported Aug 27, 2014
Wockhardt Metoprolol Succinate Extended-Release Tablets, USP 200 mg, a) 100-count bottle (NDC 64679-737-02), b)…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Wockhardt USA Inc.
Matched: Brand · Product · Product details — Failed Dissolution Specifications: Dissolution failures found during testing of control samples at the four hour time point.
FDA (openFDA drug enforcement)
Reported Aug 13, 2014
buPROPion HCl Extended-Release Tablets, USP (SR), 100 mg, 500-count bottle, Rx Only, Manufactured by: Wockhardt…
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.Wockhardt USA Inc.
Matched: Brand · Product · Product details — Failed Impurities/Degradation Products: Out of specification levels of the impurity m-chlorobenzoic acid were observed.
FDA (openFDA drug enforcement)
Reported Jun 4, 2014
Metoprolol Succinate Extended-Release Tablets, USP, 100 mg, 100-count bottle, Rx only. Manufactured by: Wockhardt…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Wockhardt USA Inc.
Matched: Brand · Product · Product details — Failed Dissolution Specifications: Failure of dissolution test observed at three month time point.
FDA (openFDA drug enforcement)
Reported May 14, 2014
Metoprolol Succinate Extended-Release Tablets, USP, 50 mg, 30-count bottle, Rx only, Manufactured by: Wockhardt…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Wockhardt USA Inc.
Matched: Brand · Product · Product details — Failed Dissolution Specifications: failure of dissolution test observed at nine month time point.
FDA (openFDA drug enforcement)
Reported Feb 5, 2014
Pantaprazole Sodium Delayed Release Tablets , USP 40 mg, 1000 tablets bottle, Rx only. Manufactured by: Wockhardt…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Wockhardt USA Inc.
Matched: Brand · Product · Product details — Failed Dissolution Specifications; 12 month acid dissolution test results were above upper limit specifications.
FDA (openFDA drug enforcement)
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