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Dear Recalling Firm,
Re: Your Voluntary Recall
This is to obtain more information concerning your firm's Voluntary Recall Action Plan.
Please answer the following in as great of detail as possible, keeping it simple. Please follow the number format below, and provide answers directly on the form. Where a table, spreadsheet, etc is requested, please provide an electronic file.
DO NOT MODIFY OR DELETE ANY QUESTION(S) OR PART THEREOF.
ANSWER EACH QUESTION AS IS.
1. PRODUCT(S)
IF THE PRODUCT IS A DRUG , INCLUDE:
a. Name of product(s): Children’s Diphenhydramine HCl Oral solution 12.5mg/5mL
b. Brand Name: Not Applicable
c. NDC# 55910-991-
d. NDA/ANDA#: N/A
e. Type or form (tablets, capsule, liquid, etc.): Liquid
f. Strength per dose, dosage: 12.5mg/5mL
g. State Rx or OTC:. OTC
h. Container description, primary through shipping (in paper cartons, in glass jars, further packed in cartons, etc): 8 OZ Translucent Prolypropylene round bottles fitted with 24mmneck finish fitted with 24mm Child resistant closure with induction sealing liner with 20ml cup with markings 5mL and 10mL graduations labelled and cartooned and packaged in to 3ply corrugated shipper 14.75X14.75X6.5625, 36 pack shipper.
i. Provide Product Indication (A brief description of the product and its use.): Diphenhydramine HCl is over the counter drug is used to treat allergies and Hay fever.
j. Date(s) of Manufacture. Please give both the beginning and ending dates (e.g. 12/15/00 to 03/30/00):
FEI/CFN:
4. REASON FOR RECALL
a. State simply WHY your firm decided to recall the product(s).
b. When and how did your firm DISCOVER THE REASON for recall [problem description]?
c. What is the ROOT CAUSE of the reason for recall?
Include any analytical finding in qualitative and/or quantitative terms, indicating whether your firm's analysis or private laboratory was involved. Provide copies of test results/lab results, analytical worksheets, methodology used, if any.
d. Is the root cause of the problem related to:
d.i. STERILITY deficiency : YES [ ] NO [ ]
d.ii. PACKAGING deficiency: YES [ ] NO [ ]
e. What type of ILLNESS or INJURY may be caused by the problem?
f. What is the TOTAL number of reports of ILLNESS or INJURY COMPLAINTS received regarding recall product? Please provide copies of such report.
g. What is the TOTAL number of reports of PRODUCT DEFECT COMPLAINTS received regarding the recall product? Please provide copies of such report.
c. What is the TOTAL amount of each recall product remaining at your firm?
d. What were the DATES of distribution? Please include both beginning and ending date. (e.g. 1/14/00 to 4/15/00 )
e. Provide an ESTIMATE (%) of the amount of product that may be recovered.
6. DISTRIBUTION PATTERN
Please provide 3 separate consignee lists/tables/spreadsheets as indicated below.
- U.S. consignees (customers who received the recall product) with Full Names, Addresses, Contact Info
- U.S. Government Agency consignees (customers who received the recall product) with Full Names, Addresses, Contact Info
- Foreign consignees (customers who received the recall product) with Full Names, Addresses, Contact Info
Please Note: The consignee list is not your customer list, it is a list of those entities that received the recall product.
Please fill in the table below as to the number of each type of consignee, for U.S. only, including Government consignees.
Consignees Approx. Number Consignees Approx. Number Distributor Repacker/Relabeler Retailer Direct Accounts Institution Veterans Administration Medical Facility Department of Defense Internet Sales Manufacturer Physician USDA Consumer/Patient Other
7. FIRM'S RECALL STRATEGY
The following questions are provided to assist you in describing your recall strategy in DETAIL as follows:
a. Date your firm was aware a recall was necessary.
c. How do you plan to NOTIFY all the consignees affected by this recall?
- Press release, letter, telefax, telephone, e-mail, visit, etc.
d. How do you plan to undertake a SUB-RECALL? (If the product is
distributed to wholesale dealers/distributors/retailers)
- Provide follow-up letters to wholesalers, e.g., wholesalers are requested to forward copies of your recall letters and response forms to their customers, etc.
e. How do you plan to monitor the number of consignees NON- RESPONDING to the recall communication?
- Include envelopes and return/reply cards, via response form mailed, certified mailing with return receipt, visit, telephone follow-up call, etc.
f. How do you plan to do EFFECTIVENESS CHECKS of this recall?
- By response form mailed, certified mailing with return receipt, etc.
- Telefax, telephone, e-mail, visit, follow-up letter, etc.
g. Date your firm ceased further distribution of the product(s).
h. How do you plan to STORE the recalled product? (if returned)
- Quarantine, locked stored, etc.
[NOTE: It is equally important to assure that all returned merchandise is promptly inventoried, handled, and stored in such a manner as to assure its separation from acceptable materials so it will not inadvertently be used or shipped. Our past experience in similar situations has shown that the longer a defective product is held between the initiation and termination of a recall, the greater the chance of its accidental misuse.]
i. What will be the final DISPOSITION of the recalled products?
- Destroy, recondition, correct label, field correct by firm's personnel, etc.
Please Note: Any destruction or reconditioning of recalled items may require FDA supervision.
8. Recall Contact
Provide the full name (including middle initial) and title of the most responsible individual to contact regarding the recall. Please also include his/her full address, telephone, fax number and e-mail address.
Name:
Organization:
Address:
Direct:
Email:
11. PLEASE PROVIDE THE FOLLOWING DOCUMENTS:
PRODUCT LABEL(s): Label(s) and labeling(s): Please be sure to include the immediate package labels, inserts, UPCs, manuals/directions for use, sales material, etc.
For press releases, please also include a digital photo of the principal display panel as the product may appear on a retail shelf or to a consumer.
Refer attachment # 1
Refer attachment # 2
Refer attachment # 3
Please visit the following link to see examples of labeling and photos from actual recalled product posted on the FDA website: http://www.fda.gov/Safety/Recalls/default.htm
CUSTOMER LETTER(s): Notification letter(s) to consignees, recall letter(s) or voluntary recall letter(s)
Refer attachment # for Recall Letter
Lisa Mathew
Division of Pharmaceutical Quality Operations I 10 Waterview Blvd., 3rd Floor Parsippany, NJ 07054 Phone: 973-331- Fax: 973-331- [email protected]
Thank you for your cooperation and efforts.
