Methylphenidate Hydrochloride Extended-release Tablets, USP, 36 mg, 100-count bottle, Rx only, Trigen Laboratories, LLC Bridgewater, NJ 08807. NDC 13811-708-10
Reported: March 14, 2018 Initiated: February 28, 2018 #D-0581-2018
Product Description
Methylphenidate Hydrochloride Extended-release Tablets, USP, 36 mg, 100-count bottle, Rx only, Trigen Laboratories, LLC Bridgewater, NJ 08807. NDC 13811-708-10
Reason for Recall
Subpotent Drug:100-count product bottle labeled as Methylphenidate HCL ER Tablets 36 mg found to contain 1 27 mg Methylphenidate HCL ER Tablet.
Details
- Recalling Firm
- Osmotica Pharmaceutical Corp
- Units Affected
- 19,664 100-bottles
- Distribution
- Nationwide in the USA
- Location
- Marietta, GA
Frequently Asked Questions
What product was recalled? ▼
Methylphenidate Hydrochloride Extended-release Tablets, USP, 36 mg, 100-count bottle, Rx only, Trigen Laboratories, LLC Bridgewater, NJ 08807. NDC 13811-708-10. Recalled by Osmotica Pharmaceutical Corp. Units affected: 19,664 100-bottles.
Why was this product recalled? ▼
Subpotent Drug:100-count product bottle labeled as Methylphenidate HCL ER Tablets 36 mg found to contain 1 27 mg Methylphenidate HCL ER Tablet.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on March 14, 2018. Severity: Low. Recall number: D-0581-2018.
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