Why it was recalled
Microbial Contamination of Non-sterile Products: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii).
Product description
Diphenhydramine HCL Liquid, 12.5 mg/5 mL, 4 oz bottle, Manufactured by Torrent Pharma, Inc., Levittown, PA 19057, NDC 52959-0123-03.
Lot numbers, UPCs & expiration codes
Lot #: DHI56M, Exp. 12/19
Where it was sold
Nationwide Within 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-1430-2019
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Jun 24, 2019
- FDA report date
- Jul 3, 2019
- Quantity
- 12 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- H J Harkins Company Inc dba Pharma Pac
Original FDA data
Every field from FDA enforcement report D-1430-2019, exactly as published.
Show all FDA fields
- City
- Grover Beach
- State
- CA
- Status
- Terminated
- Country
- United States
- Event ID
- 83195
- Address
- 1400 W Grand Ave Ste F
- Code information
- Lot #: DHI56M, Exp. 12/19
- Postal code
- 93433-4221
- Report date
- Jul 3, 2019
- Product type
- Drugs
- Recall number
- D-1430-2019
- Classification
- Class II
- Recalling firm
- H J Harkins Company Inc dba Pharma Pac
- Product quantity
- 12 bottles
- Termination date
- May 24, 2023
- Reason for recall
- Microbial Contamination of Non-sterile Products: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii).
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Diphenhydramine HCL Liquid, 12.5 mg/5 mL, 4 oz bottle, Manufactured by Torrent Pharma, Inc., Levittown, PA 19057, NDC 52959-0123-03.
- Distribution pattern
- Nationwide Within the United States
- Recall initiation date
- Jun 24, 2019
- Center classification date
- Jun 27, 2019