Why it was recalled
Subpotent Drug: During routine stability testing one tablet was found with tablet weight below specification.
Product description
Clonazepam Tablets, USP 2 mg 100 tablets Manufactured by: Actavis Elizabeth LLC 200 Elmora Avenue, Elizabeth, NJ 0737 USA NDC 0228-3005-11 packaged in White/Round HDPE 75 CC with white/round plastic 33 mm CRC closure shipped in corrugated 75 cc carton (24 bottles/carton)
Lot numbers, UPCs & expiration codes
lot 58468552 Exp. 05/15
Where it was sold
Nationwide
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-1087-2014
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Nov 6, 2013
- FDA report date
- Mar 5, 2014
- Quantity
- 13,608 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Actavis Elizabeth LLC
Original FDA data
Every field from FDA enforcement report D-1087-2014, exactly as published.
Show all FDA fields
- City
- Elizabeth
- State
- NJ
- Status
- Terminated
- Country
- United States
- Event ID
- 67053
- Address
- 200 Elmora Ave
- Code information
- lot 58468552 Exp. 05/15
- Postal code
- 07202-1106
- Report date
- Mar 5, 2014
- Product type
- Drugs
- Recall number
- D-1087-2014
- Classification
- Class II
- Recalling firm
- Actavis Elizabeth LLC
- Product quantity
- 13,608 bottles
- Termination date
- Jun 2, 2014
- Reason for recall
- Subpotent Drug: During routine stability testing one tablet was found with tablet weight below specification.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Clonazepam Tablets, USP 2 mg 100 tablets Manufactured by: Actavis Elizabeth LLC 200 Elmora Avenue, Elizabeth, NJ 0737 USA NDC 0228-3005-11 packaged in White/Round HDPE 75 CC with white/round plastic 33 mm CRC closure shipped in corrugated 75 cc carton (24 bottles/carton)
- Distribution pattern
- Nationwide
- Recall initiation date
- Nov 6, 2013
- Initial firm notification
- Letter
- Center classification date
- Feb 21, 2014