Why it was recalled
CGMP Deviations: Out of specification (OOS) test result for Total Aerobic Microbial Count (TAMC) and Total Yeast and Mold Count (TYMC) for an excipient batch of Dibasic Calcium Phosphate.
Product description
Cyclobenzaprine Hydrochloride Tablets, 7.5mg, 100 count tablets per bottle, Rx Only, Manufactured by: Actavis Laboratories FL, Inc. Fort Lauderdale, FL 33314, NDC 70199-014-01
Lot numbers, UPCs & expiration codes
1408822A, exp. date 08/2023 (labeler - Casper)
Where it was sold
Product was distributed 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-0775-2021
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Jul 29, 2021
- FDA report date
- Sep 8, 2021
- Quantity
- 4,587 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Teva Pharmaceuticals USA
Original FDA data
Every field from FDA enforcement report D-0775-2021, exactly as published.
Show all FDA fields
- City
- Parsippany
- State
- NJ
- Status
- Terminated
- Country
- United States
- Event ID
- 88370
- Address
- 400 Interpace Pkwy
- Code information
- 1408822A, exp. date 08/2023 (labeler - Casper)
- Postal code
- 07054-1120
- Report date
- Sep 8, 2021
- Product type
- Drugs
- Recall number
- D-0775-2021
- Classification
- Class II
- Recalling firm
- Teva Pharmaceuticals USA
- Product quantity
- 4,587 bottles
- Termination date
- Nov 4, 2022
- Reason for recall
- CGMP Deviations: Out of specification (OOS) test result for Total Aerobic Microbial Count (TAMC) and Total Yeast and Mold Count (TYMC) for an excipient batch of Dibasic Calcium Phosphate.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Cyclobenzaprine Hydrochloride Tablets, 7.5mg, 100 count tablets per bottle, Rx Only, Manufactured by: Actavis Laboratories FL, Inc. Fort Lauderdale, FL 33314, NDC 70199-014-01
- Distribution pattern
- Product was distributed nationwide.
- Recall initiation date
- Jul 29, 2021
- Initial firm notification
- Letter
- Center classification date
- Aug 27, 2021