Why it was recalled
Presence of foreign substance: Ibuprofen Oral Suspension USP may have small particles of an inert plastic material introduced during manufacturing.
Product description
Ibuprofen Oral Suspension USP, 100 mg/5mL, 4 fl.oz. 118 mL, Rx only, Preferred Pharmaceuticals, Inc., Anaheim, CA. Mfg: Taro Pharm.; Hawthorne, NY; NDC 68788-7268-01
Lot numbers, UPCs & expiration codes
Lot #: I1718U, Exp. 3/2020; K0818L, Exp. 9/2020; L2718E, Exp. 9/2020; A2219E, Exp. 9/2020; C1519S, Exp. 12/2020; C2819Y, Exp. 12/2020; E2019V, Exp. 11/2020
Where it was sold
CA, FL, IL
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-0531-2020
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Nov 21, 2019
- FDA report date
- Dec 4, 2019
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Preferred Pharmaceuticals, Inc
Original FDA data
Every field from FDA enforcement report D-0531-2020, exactly as published.
Show all FDA fields
- City
- Anaheim
- State
- CA
- Status
- Terminated
- Country
- United States
- Event ID
- 84359
- Address
- 1250 N Lakeview Ave Ste O
- Code information
- Lot #: I1718U, Exp. 3/2020; K0818L, Exp. 9/2020; L2718E, Exp. 9/2020; A2219E, Exp. 9/2020; C1519S, Exp. 12/2020; C2819Y, Exp. 12/2020; E2019V, Exp. 11/2020
- Postal code
- 92807-1801
- Report date
- Dec 4, 2019
- Product type
- Drugs
- Recall number
- D-0531-2020
- Classification
- Class II
- Recalling firm
- Preferred Pharmaceuticals, Inc
- Termination date
- May 11, 2023
- Reason for recall
- Presence of foreign substance: Ibuprofen Oral Suspension USP may have small particles of an inert plastic material introduced during manufacturing.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Ibuprofen Oral Suspension USP, 100 mg/5mL, 4 fl.oz. 118 mL, Rx only, Preferred Pharmaceuticals, Inc., Anaheim, CA. Mfg: Taro Pharm.; Hawthorne, NY; NDC 68788-7268-01
- Distribution pattern
- CA, FL, IL
- Recall initiation date
- Nov 21, 2019
- Initial firm notification
- Telephone
- Center classification date
- Nov 27, 2019