Why it was recalled
Failed Dissolution Specifications: Out of specification result during long term testing in Tetracycline HCl capsules.
Product description
Tetracycline HCL Capsules, USP, 500 mg, 100-count Bottle, Rx Only, Manufactured for: Heritage Pharmaceuticals Inc. East Brunswick NJ 08816. NDC 23155-018-01
Lot numbers, UPCs & expiration codes
Lot #s: G190609, G190610, G190611, Exp Jun 2022: L191027, L191028, Exp Nov 2022: K190953, K190952, Exp Oct 2022
Where it was sold
Distributed Nationwide in the US
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-1254-2020
- Classification
- Class I
- Status
- Terminated
- Recall initiated
- Mar 23, 2020
- FDA report date
- Apr 15, 2020
- Quantity
- 17,524 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Avet Pharmaceuticals, Inc.
Original FDA data
Every field from FDA enforcement report D-1254-2020, exactly as published.
Show all FDA fields
- City
- East Brunswick
- State
- NJ
- Status
- Terminated
- Country
- United States
- Event ID
- 85307
- Address
- 1 Tower Center Blvd Ste 1700
- Code information
- Lot #s: G190609, G190610, G190611, Exp Jun 2022: L191027, L191028, Exp Nov 2022: K190953, K190952, Exp Oct 2022
- Postal code
- 08816-1145
- Report date
- Apr 15, 2020
- Product type
- Drugs
- Recall number
- D-1254-2020
- Classification
- Class I
- Recalling firm
- Avet Pharmaceuticals, Inc.
- Product quantity
- 17,524 bottles
- Termination date
- Aug 23, 2022
- Reason for recall
- Failed Dissolution Specifications: Out of specification result during long term testing in Tetracycline HCl capsules.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Tetracycline HCL Capsules, USP, 500 mg, 100-count Bottle, Rx Only, Manufactured for: Heritage Pharmaceuticals Inc. East Brunswick NJ 08816. NDC 23155-018-01
- Distribution pattern
- Distributed Nationwide in the US
- Recall initiation date
- Mar 23, 2020
- Initial firm notification
- Letter
- Center classification date
- Apr 27, 2020