D-1458-2016 Class II Terminated
FDA drug recall D-1458-2016 was initiated by Golden State Medical Supply Inc. on Aug 3, 2016 and is designated Class II. Reason for recall: Failed Dissolution Specifications: Out-of-specification results in retained sample. The recall status is terminated (terminated Feb 2, 2017). Affected quantity: 65,401 bottles.
Recall details
- Product Type
- Drugs
- Report Date
- Aug 24, 2016
- Initiation Date
- Aug 3, 2016
- Termination Date
- Feb 2, 2017
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 65,401 bottles
Product description
Venlafaxine Hydrochloride Extended-Release Capsules, 150 mg, a) 30 capsules per bottle, NDC # 60429-123-30, b) 90 capsules per bottle, NDC # 60429-123-90, Rx Only, GSMS.
Reason for recall
Failed Dissolution Specifications: Out-of-specification results in retained sample.
Distribution pattern
Nationwide
Code information
Lot #: a) GS011931, Exp 10/2017; GS011932, Exp 11/2017 b) GS010773, GS011242, 09/2017; GS011061, GS011315, GS011357, GS011585, GS011586, GS011588, GS011591, Exp 10/2017; GS011933, Exp 11/2017
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-1458-2016
- openFDA file date
- Nov 10, 2026
- Loaded by RegDataLab
- Nov 11, 2026