Methylphenidate Hydrochloride Extended-Release Capsules (LA), 40 mg, 100 count bottle, Rx only, TEVA PHARMACEUTICALS USA, NDC 0093-5348-01
Reported: August 14, 2013 Initiated: June 18, 2013 #D-849-2013
Product Description
Methylphenidate Hydrochloride Extended-Release Capsules (LA), 40 mg, 100 count bottle, Rx only, TEVA PHARMACEUTICALS USA, NDC 0093-5348-01
Reason for Recall
Failed Dissolution Specifications: Product is being recalled due to out of specification dissolution results obtained during routine stability testing.
Details
- Recalling Firm
- Teva Pharmaceuticals USA, Inc.
- Units Affected
- 7,579 bottles
- Distribution
- Nationwide
- Location
- Sellersville, PA
Frequently Asked Questions
What product was recalled? ▼
Methylphenidate Hydrochloride Extended-Release Capsules (LA), 40 mg, 100 count bottle, Rx only, TEVA PHARMACEUTICALS USA, NDC 0093-5348-01. Recalled by Teva Pharmaceuticals USA, Inc.. Units affected: 7,579 bottles.
Why was this product recalled? ▼
Failed Dissolution Specifications: Product is being recalled due to out of specification dissolution results obtained during routine stability testing.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on August 14, 2013. Severity: Moderate. Recall number: D-849-2013.
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