FDA-Drug2018-10-10Class IIPROCESSING DEFECT
Teva Clozapine 12.5 mg orally disintegrating tablets recalled for failed disintegration
OTHERNationwide distribution
Stop using Teva Clozapine 12.5 mg tablets
Teva Pharmaceuticals is recalling Clozapine 12.5 mg orally disintegrating tablets (Lot #34034024B, expiration 02/20) because they failed quality testing for proper disintegration. The tablets may not dissolve as intended, which could affect how the medication is absorbed in your body.
- Check if you have Clozapine 12.5 mg tablets with lot number 34034024B and expiration date 02/20
- Stop taking tablets from this lot and do not use them
- Contact your pharmacy or doctor for a replacement or alternative medication
- Do not throw away your medication; your pharmacy can help you dispose of it safely
Hazard
Failed Disintegration Specifications: Out-of-specification disintegration test result obtained during routine stability testing.
Sold states
Distributed nationwide in the USA
Affected count
313 bottles
Manufactured in
1090 Horsham Rd, North Wales, PA, United States
Products
Clozapine Orally Disintegrating Tablets, 12.5 mg, 100-count bottles, Rx only, Teva Pharmaceuticals USA, Inc., North Wales, PA 19454, NDC 0093-5416-01 Yellow, round, flat-faced, beveled-edge, unscored tablet. Debossed with 13 on one side and plain on the other side.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0001-2019Don't want to check this manually?
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