Why it was recalled
CGMP Deviations: manufactured under the same conditions as those found to be subpotent.
Product description
WP Thyroid, Westhroid Pure, Thyroid USP, [liothyronine (T3) 2.25 mcg and levothyroxine (T4) 9.5 mcg], 1/4 Grain (16.25 mg) Tablets, packaged in a) 30-count bottles, NDC 64727-5450-4; b) 60-count bottles, NDC 64727-5450-5; c) 90-count bottles, NDC 64727-5450-6; d) 100-count bottles, NDC 64727-5450-1; and e) 1,000-count bottles, NDC 64727-5450-2; Rx only, Manufactured by: RLC Labs Phoenix, AZ 85034.
Lot numbers, UPCs & expiration codes
All lots with expiry between 10/2020-07/2023
Where it was sold
Nationwide in the United States
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-1606-2020
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Aug 25, 2020
- FDA report date
- Sep 23, 2020
- Quantity
- N/A
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- RLC Labs Inc.
Original FDA data
Every field from FDA enforcement report D-1606-2020, exactly as published.
Show all FDA fields
- City
- Phoenix
- State
- AZ
- Status
- Terminated
- Country
- United States
- Event ID
- 86343
- Address
- 1850 E Riverview Dr
- Code information
- All lots with expiry between 10/2020-07/2023
- Postal code
- 85034-6703
- Report date
- Sep 23, 2020
- Product type
- Drugs
- Recall number
- D-1606-2020
- Classification
- Class II
- Recalling firm
- RLC Labs Inc.
- Termination date
- Nov 8, 2023
- Reason for recall
- CGMP Deviations: manufactured under the same conditions as those found to be subpotent.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- WP Thyroid, Westhroid Pure, Thyroid USP, [liothyronine (T3) 2.25 mcg and levothyroxine (T4) 9.5 mcg], 1/4 Grain (16.25 mg) Tablets, packaged in a) 30-count bottles, NDC 64727-5450-4; b) 60-count bottles, NDC 64727-5450-5; c) 90-count bottles, NDC 64727-5450-6; d) 100-count bottles, NDC 64727-5450-1; and e) 1,000-count bottles, NDC 64727-5450-2; Rx only, Manufactured by: RLC Labs Phoenix, AZ 85034.
- Distribution pattern
- Nationwide in the United States
- Recall initiation date
- Aug 25, 2020
- Initial firm notification
- Center classification date
- Sep 24, 2020