Multi-event May 2013 FDA Recall Drug by Lowlite Investments, Inc. D/b/a Olympia Pharmacy
This Multi-event Class II drug recall was voluntarily initiated by Lowlite Investments, Inc. D/b/a Olympia Pharmacy on May 29, 2013 for the product Drug. The FDA reported the reason for recall as lack of assurance of sterility. The product was distributed Nationwide and the recall is currently ongoing.
Reported Recall Events
D-716-2013 D-765-2013 D-768-2013 D-753-2013 D-796-2013 D-772-2013 D-776-2013 D-742-2013 D-783-2013 D-767-2013 D-702-2013 D-720-2013 D-794-2013 D-789-2013 D-747-2013 D-784-2013 D-710-2013 D-775-2013 D-738-2013 D-721-2013 D-706-2013 D-757-2013 D-751-013 D-790-2013 D-698-2013 D-779-2013 D-754-2013 D-722-2013 D-725-2013 D-704-2013 D-703-2013 D-743-2013 D-707-2013 D-778-2013 D-750-2013 D-758-2013 D-759-2013 D-726-2013 D-780-2013 D-770-2013 D-727-2013 D-785-2013 D-752-2013 D-781-2013 D-724-2013 D-761-2013 D-695-2013 D-755-2013 D-777-2013 D-715-2013 D-787-2013 D-749-2013 D-766-2013 D-774-2013 D-762-2013 D-795-2013 D-735-2013 D-740-2013 D-717-2013 D-745-2013 D-708-2013 D-705-2013 D-739-2013 D-718-2013 D-729-2013 D-736-2013 D-793-2013 D-773-2013 D-728-2013 D-734-2013 D-719-2013 D-700-2013 D-788-2013 D-741-2013 D-771-2013 D-786-2013 D-791-2013 D-694-2013 D-692-2013 D-760-2013 D-701-2013 D-746-2013 D-713-2013 D-714-2013 D-730-2013 D-732-2013 D-699-2013 D-696-2013 D-733-2013 D-769-2013 D-737-2013 D-693-2013 D-697-2013 D-712-2013 D-756-2013 D-792-2013 D-782-2013 D-709-2013 D-763-2013 D-748-2013 D-731-2013 D-744-2013 D-711-2013 D-723-2013 D-764-2013
Recall Number: D-716-2013
Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes
05-29-2013
07-17-2013
2
Recall Profile & Regulatory Data
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Ongoing
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Lowlite Investments, Inc. D/B/A Olympia Pharmacy
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Nationwide and PR
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Deslorelin 15 mg vial, compounded by Olympia Pharmacy, Orlando, FL
Batch or Lot Expiration Information
Lot# A3021 Exp 6/2/13 and L5011 exp 12/11/13
Recall Number: D-765-2013
Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes
05-29-2013
07-17-2013
6
Recall Profile & Regulatory Data
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Ongoing
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Lowlite Investments, Inc. D/B/A Olympia Pharmacy
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Nationwide and PR
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Papaverine 40 mg/ml Injection, compounded by Olympia Pharmacy, Orlando, FL
Batch or Lot Expiration Information
Lot# B0021 Exp 8/31/13, B0013 Exp 8/1/13, C5122 Exp 9/22/13, C51101 Exp 8/1/13, C5508 Exp 9/8/13, and C5119 Exp 9/19/13
Recall Number: D-768-2013
Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes
05-29-2013
07-17-2013
3
Recall Profile & Regulatory Data
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Ongoing
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Lowlite Investments, Inc. D/B/A Olympia Pharmacy
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Nationwide and PR
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Pentosan 250 mg/ml Injection, compounded by Olympia Pharmacy, Orlando, FL
Batch or Lot Expiration Information
Lot# K5629 Exp 11/30/13, C51013 Exp 9/10/13 and C5513 Exp 9/14/13
Recall Number: D-753-2013
Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes
05-29-2013
07-17-2013
1
Recall Profile & Regulatory Data
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Ongoing
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Lowlite Investments, Inc. D/B/A Olympia Pharmacy
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Nationwide and PR
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Metabolase Forte Injection, compounded by Olympia Pharmacy, Orlando, FL
Batch or Lot Expiration Information
Lot# B5021 Exp 9/30/13
Recall Number: D-796-2013
Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes
05-29-2013
07-17-2013
1
Recall Profile & Regulatory Data
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Ongoing
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Lowlite Investments, Inc. D/B/A Olympia Pharmacy
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Nationwide and PR
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Yohimbine 10 mg/ml Injection, compounded by Olympia Pharmacy, Orlando, FL
Batch or Lot Expiration Information
Lot# A5008 Exp 12/31/13
Recall Number: D-772-2013
Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes
05-29-2013
07-17-2013
4
Recall Profile & Regulatory Data
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Ongoing
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Lowlite Investments, Inc. D/B/A Olympia Pharmacy
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Nationwide and PR
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Phenylephrine 1 mg/ml Injection, compounded by Olympia Pharmacy, Orlando, FL
Batch or Lot Expiration Information
Lot# L5017 Exp 10/31/13, C51301 Exp 9/30/13, B5312 Exp 8/31/13, and A5209 Exp 11/01/13
Recall Number: D-776-2013
Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes
05-29-2013
07-17-2013
1
Recall Profile & Regulatory Data
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Ongoing
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Lowlite Investments, Inc. D/B/A Olympia Pharmacy
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Nationwide and PR
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Progesterone 100 mg/ml in Olive Oil Injection, compounded by Olympia Pharmacy, Orlando, FL
Batch or Lot Expiration Information
Lot# B5007 Exp 8/7/13
Recall Number: D-742-2013
Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes
05-29-2013
07-17-2013
1
Recall Profile & Regulatory Data
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Ongoing
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Lowlite Investments, Inc. D/B/A Olympia Pharmacy
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Nationwide and PR
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Idoxuridine 0.1% Injection, compounded by Olympia Pharmacy, Orlando, FL
Batch or Lot Expiration Information
Lot# L5703 Exp 11/30/2013
Recall Number: D-783-2013
Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes
05-29-2013
07-17-2013
3
Recall Profile & Regulatory Data
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Ongoing
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Lowlite Investments, Inc. D/B/A Olympia Pharmacy
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Nationwide and PR
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Stanozolol (50 mg/ml and 100 mg/ml) Injection, compounded by Olympia Pharmacy, Orlando, FL
Batch or Lot Expiration Information
Lot# 50mg/ml = Lots B5727 Exp 8/27/13, and C5708 Exp 9/8/13 // 100,g/ml =Lot C5706 Exp 9/6/13
Recall Number: D-767-2013
Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes
05-29-2013
07-17-2013
1
Recall Profile & Regulatory Data
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Ongoing
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Lowlite Investments, Inc. D/B/A Olympia Pharmacy
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Nationwide and PR
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Pento-Gluc 200 mg/ml Injection, compounded by Olympia Pharmacy, Orlando, FL
Batch or Lot Expiration Information
Lot# B0521 Exp 8/21/13
Recall Number: D-702-2013
Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes
05-29-2013
07-17-2013
1
Recall Profile & Regulatory Data
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Ongoing
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Lowlite Investments, Inc. D/B/A Olympia Pharmacy
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Nationwide and PR
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Atropine Sulfate 50 mg/ml Injection, compounded by Olympia Pharmacy, Orlando, FL
Batch or Lot Expiration Information
Lot# C5115 Exp 9/11/13
Recall Number: D-720-2013
Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes
05-29-2013
07-17-2013
1
Recall Profile & Regulatory Data
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Ongoing
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Lowlite Investments, Inc. D/B/A Olympia Pharmacy
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Nationwide and PR
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Dexpanthenol 250 mg/ml Injection, compounded by Olympia Pharmacy, Orlando, FL
Batch or Lot Expiration Information
Lot# I5406 Exp 9/30/13
Recall Number: D-794-2013
Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes
05-29-2013
07-17-2013
1
Recall Profile & Regulatory Data
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Ongoing
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Lowlite Investments, Inc. D/B/A Olympia Pharmacy
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Nationwide and PR
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Voriconazole 5% Ophthalmic drop compounded by Olympia Pharmacy, Orlando, FL
Batch or Lot Expiration Information
Lot# A5615 Exp 6/6/13
Recall Number: D-789-2013
Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes
05-29-2013
07-17-2013
1
Recall Profile & Regulatory Data
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Ongoing
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Lowlite Investments, Inc. D/B/A Olympia Pharmacy
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Nationwide and PR
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Vitamin 15 (HEMO15) Injection, compounded by Olympia Pharmacy, Orlando, FL
Batch or Lot Expiration Information
Lot# A5011 Exp 7/10/13
Recall Number: D-747-2013
Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes
05-29-2013
07-17-2013
1
Recall Profile & Regulatory Data
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Ongoing
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Lowlite Investments, Inc. D/B/A Olympia Pharmacy
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Nationwide and PR
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
L-ArGiNINE 200 mg/ml Injection, compounded by Olympia Pharmacy, Orlando, FL
Batch or Lot Expiration Information
Lot# B0005 Exp 8/5/13
Recall Number: D-784-2013
Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes
05-29-2013
07-17-2013
2
Recall Profile & Regulatory Data
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Ongoing
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Lowlite Investments, Inc. D/B/A Olympia Pharmacy
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Nationwide and PR
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Tacrolimus (0.02% and 0.03%) drops, compounded by Olympia Pharmacy, Orlando, FL
Batch or Lot Expiration Information
Lot# C51012 Exp 9/12/13 and C51201 Exp 9/6/13
Recall Number: D-710-2013
Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes
05-29-2013
07-17-2013
1
Recall Profile & Regulatory Data
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Ongoing
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Lowlite Investments, Inc. D/B/A Olympia Pharmacy
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Nationwide and PR
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Calcium Gluconate 23%, compounded by Olympia Pharmacy, Orlando, FL
Batch or Lot Expiration Information
Lot# A5914 Exp 12/31/13
Recall Number: D-775-2013
Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes
05-29-2013
07-17-2013
1
Recall Profile & Regulatory Data
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Ongoing
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Lowlite Investments, Inc. D/B/A Olympia Pharmacy
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Nationwide and PR
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Praziquantel 56.8mg/ml Injection, compounded by Olympia Pharmacy, Orlando, FL
Batch or Lot Expiration Information
Lot# L3320 Exp 12/31/13
Recall Number: D-738-2013
Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes
05-29-2013
07-17-2013
1
Recall Profile & Regulatory Data
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Ongoing
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Lowlite Investments, Inc. D/B/A Olympia Pharmacy
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Nationwide and PR
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Guanabenz 20 mg/ml Injection, compounded by Olympia Pharmacy, Orlando, FL
Batch or Lot Expiration Information
Lot# A0422 Exp 7/31/13
Recall Number: D-721-2013
Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes
05-29-2013
07-17-2013
1
Recall Profile & Regulatory Data
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Ongoing
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Lowlite Investments, Inc. D/B/A Olympia Pharmacy
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Nationwide and PR
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Dextrose 50% Solution, compounded by Olympia Pharmacy, Orlando, FL
Batch or Lot Expiration Information
Lot# A5414 Exp 12/31/13
Recall Number: D-706-2013
Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes
05-29-2013
07-17-2013
4
Recall Profile & Regulatory Data
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Ongoing
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Lowlite Investments, Inc. D/B/A Olympia Pharmacy
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Nationwide and PR
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Bi mix, compounded by Olympia Pharmacy, Orlando, FL
Batch or Lot Expiration Information
Lot# A5028 Exp 6/2/13, B5011 exp 6/1/13, C4112 Exp 6/1/13, and C4208 Exp 6/20/13
Recall Number: D-757-2013
Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes
05-29-2013
07-17-2013
2
Recall Profile & Regulatory Data
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Ongoing
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Lowlite Investments, Inc. D/B/A Olympia Pharmacy
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Nationwide and PR
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Methylcobalamin 25 mg/ml Inj and 5000 mcg/ml Injection, compounded by Olympia Pharmacy, Orlando, FL
Batch or Lot Expiration Information
Lot# 25mg/ml Inj Lot L3620 Exp 12/31/13 5000mcg/ml Inj Lot A3328 Exp 6/28/13
Recall Number: D-751-013
Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes
05-29-2013
07-17-2013
1
Recall Profile & Regulatory Data
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Ongoing
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Lowlite Investments, Inc. D/B/A Olympia Pharmacy
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Nationwide and PR
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Medroxyprogesterone 150 mg/ml Injection, compounded by Olympia Pharmacy, Orlando, FL
Batch or Lot Expiration Information
Lot# L3727 Exp 6/1/13
Recall Number: D-790-2013
Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes
05-29-2013
07-17-2013
1
Recall Profile & Regulatory Data
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Ongoing
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Lowlite Investments, Inc. D/B/A Olympia Pharmacy
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Nationwide and PR
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Vitamin A/D3/E Olive Oil Injection, compounded by Olympia Pharmacy, Orlando, FL
Batch or Lot Expiration Information
Lot# L5303 Exp 11/30/13
Recall Number: D-698-2013
Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes
05-29-2013
07-17-2013
1
Recall Profile & Regulatory Data
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Ongoing
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Lowlite Investments, Inc. D/B/A Olympia Pharmacy
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Nationwide and PR
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Aminocaproic Acid 250 mg/ml Injection, compounded by Olympia Pharmacy, Orlando, FL
Batch or Lot Expiration Information
Lot# B3727 Exp 8/7/13
Recall Number: D-779-2013
Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes
05-29-2013
07-17-2013
1
Recall Profile & Regulatory Data
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Ongoing
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Lowlite Investments, Inc. D/B/A Olympia Pharmacy
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Nationwide and PR
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Sermorelin/GHRP 3 mg/3 mg vial, compounded by Olympia Pharmacy, Orlando, FL
Batch or Lot Expiration Information
Lot# A5811 Exp 11/30/13
Recall Number: D-754-2013
Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes
05-29-2013
07-17-2013
2
Recall Profile & Regulatory Data
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Ongoing
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Lowlite Investments, Inc. D/B/A Olympia Pharmacy
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Nationwide and PR
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Metabolase Injection, compounded by Olympia Pharmacy, Orlando, FL
Batch or Lot Expiration Information
Lot# B0101 Exp 10/31/13 and B0013 Exp 8/13/13
Recall Number: D-722-2013
Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes
05-29-2013
07-17-2013
1
Recall Profile & Regulatory Data
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Ongoing
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Lowlite Investments, Inc. D/B/A Olympia Pharmacy
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Nationwide and PR
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Diclazuril 10 mg/ml Injection, compounded by Olympia Pharmacy, Orlando, FL
Batch or Lot Expiration Information
Lot# B5014 Exp 8/14/13
Recall Number: D-725-2013
Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes
05-29-2013
07-17-2013
1
Recall Profile & Regulatory Data
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Ongoing
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Lowlite Investments, Inc. D/B/A Olympia Pharmacy
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Nationwide and PR
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Doxapram 20 mg/ml Injection, compounded by Olympia Pharmacy, Orlando, FL
Batch or Lot Expiration Information
Lot# B0105 Exp 8/19/13
Recall Number: D-704-2013
Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes
05-29-2013
07-17-2013
1
Recall Profile & Regulatory Data
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Ongoing
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Lowlite Investments, Inc. D/B/A Olympia Pharmacy
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Nationwide and PR
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Betamethasone Sodium Phosphate 12 mg/ml Injection, compounded by Olympia Pharmacy, Orlando, FL
Batch or Lot Expiration Information
Lot# A5719 Exp 6/7/13
Recall Number: D-703-2013
Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes
05-29-2013
07-17-2013
1
Recall Profile & Regulatory Data
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Ongoing
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Lowlite Investments, Inc. D/B/A Olympia Pharmacy
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Nationwide and PR
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Beta Alanine 100 mg/ml / l-carnosine 100 mg/ml Injection, compounded by Olympia Pharmacy, Orlando, FL
Batch or Lot Expiration Information
Lot# K4419 Exp 12/14/13
Recall Number: D-743-2013
Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes
05-29-2013
07-17-2013
1
Recall Profile & Regulatory Data
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Ongoing
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Lowlite Investments, Inc. D/B/A Olympia Pharmacy
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Nationwide and PR
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Iodine 20 mg Injection, compounded by Olympia Pharmacy, Orlando, FL
Batch or Lot Expiration Information
Lot# C51501 Exp 9/30/13
Recall Number: D-707-2013
Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes
05-29-2013
07-17-2013
1
Recall Profile & Regulatory Data
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Ongoing
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Lowlite Investments, Inc. D/B/A Olympia Pharmacy
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Nationwide and PR
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
BNP/Dexamethasone Eye Ointment, compounded by Olympia Pharmacy, Orlando, FL
Batch or Lot Expiration Information
Lot# B5119 exp 10/31/13
Recall Number: D-778-2013
Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes
05-29-2013
07-17-2013
3
Recall Profile & Regulatory Data
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Ongoing
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Lowlite Investments, Inc. D/B/A Olympia Pharmacy
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Nationwide and PR
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Quadmix, compounded by Olympia Pharmacy, Orlando, FL
Batch or Lot Expiration Information
Lot# C4526 Exp 9/4/13, B4125 exp 8/12/13, and B5014 exp 8/1/13
Recall Number: D-750-2013
Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes
05-29-2013
07-17-2013
1
Recall Profile & Regulatory Data
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Ongoing
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Lowlite Investments, Inc. D/B/A Olympia Pharmacy
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Nationwide and PR
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Medetomidine 2 mg/ml Injection, compounded by Olympia Pharmacy, Orlando, FL
Batch or Lot Expiration Information
Lot# A5714 Exp 12/31/13
Recall Number: D-758-2013
Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes
05-29-2013
07-17-2013
1
Recall Profile & Regulatory Data
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Ongoing
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Lowlite Investments, Inc. D/B/A Olympia Pharmacy
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Nationwide and PR
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Methylprednisolone Acetate 80 mg/ml Injection, compounded by Olympia, FL
Batch or Lot Expiration Information
Lot# A3104 Exp 6/4/13
Recall Number: D-759-2013
Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes
05-29-2013
07-17-2013
1
Recall Profile & Regulatory Data
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Ongoing
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Lowlite Investments, Inc. D/B/A Olympia Pharmacy
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Nationwide and PR
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Metoclopramide 5 mg/ml Injection,compounded by Olympia Pharmacy, Orlando, FL
Batch or Lot Expiration Information
Lot# A5423 Exp 12/31/13
Recall Number: D-726-2013
Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes
05-29-2013
07-17-2013
1
Recall Profile & Regulatory Data
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Ongoing
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Lowlite Investments, Inc. D/B/A Olympia Pharmacy
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Nationwide and PR
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Enrofloxacin 20 mg/ml Injection, compounded by Olympia Pharmacy, Orlando, FL
Batch or Lot Expiration Information
Lot# A5011 Exp 11/30/13
Recall Number: D-780-2013
Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes
05-29-2013
07-17-2013
1
Recall Profile & Regulatory Data
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Ongoing
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Lowlite Investments, Inc. D/B/A Olympia Pharmacy
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Nationwide and PR
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Sodium Iodide 20% Injection, compounded by Olympia Pharmacy, Orlando, FL
Batch or Lot Expiration Information
Lot# C5822 Exp 9/8/13
Recall Number: D-770-2013
Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes
05-29-2013
07-17-2013
5
Recall Profile & Regulatory Data
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Ongoing
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Lowlite Investments, Inc. D/B/A Olympia Pharmacy
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Nationwide and PR
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Phentolamine 20 mg/ml Injection, compounded by Olympia Pharmacy, Orlando, FL
Batch or Lot Expiration Information
Lot# B31012 Exp 8/31/13, B5102 Exp 8/10/13, C5228 Exp 9/22/13, B5012 Exp 12/31/13, and C5111 exp 9/11/13
Recall Number: D-727-2013
Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes
05-29-2013
07-17-2013
1
Recall Profile & Regulatory Data
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Ongoing
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Lowlite Investments, Inc. D/B/A Olympia Pharmacy
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Nationwide and PR
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Estradiol Cypionate 10 mg/ml Injection, compounded by Olympia Pharmacy, Orlando, FL
Batch or Lot Expiration Information
Lot# B5026 Exp 9/30/13
Recall Number: D-785-2013
Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes
05-29-2013
07-17-2013
1
Recall Profile & Regulatory Data
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Ongoing
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Lowlite Investments, Inc. D/B/A Olympia Pharmacy
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Nationwide and PR
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Taurine 100 mg/ml Injection, compounded by Olympia Pharmacy, Orlando, FL
Batch or Lot Expiration Information
Lot# C5629 Exp 10/31/13
Recall Number: D-752-2013
Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes
05-29-2013
07-17-2013
2
Recall Profile & Regulatory Data
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Ongoing
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Lowlite Investments, Inc. D/B/A Olympia Pharmacy
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Nationwide and PR
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Meloxicam 5 mg/ml Injection, compounded by Olympia Pharmacy, Orlando, FL
Batch or Lot Expiration Information
Lot# B5426 Exp 8/26/13 and A5110 Exp 12/1/13
Recall Number: D-781-2013
Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes
05-29-2013
07-17-2013
1
Recall Profile & Regulatory Data
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Ongoing
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Lowlite Investments, Inc. D/B/A Olympia Pharmacy
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Nationwide and PR
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Sodium Salicylate 40% Injection, compounded by Olympia Pharmacy, Orlando, FL
Batch or Lot Expiration Information
Lot# B5020 Exp 12/31/13
Recall Number: D-724-2013
Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes
05-29-2013
07-17-2013
1
Recall Profile & Regulatory Data
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Ongoing
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Lowlite Investments, Inc. D/B/A Olympia Pharmacy
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Nationwide and PR
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Disodium EDTA Injection, compounded by Olympia Pharmacy, Orlando, FL
Batch or Lot Expiration Information
Lot# A5616 Exp 7/31/13
Recall Number: D-761-2013
Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes
05-29-2013
07-17-2013
1
Recall Profile & Regulatory Data
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Ongoing
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Lowlite Investments, Inc. D/B/A Olympia Pharmacy
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Nationwide and PR
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Miconazole 3% Injection, compounded by Olympia Pharmacy, Orlando, FL
Batch or Lot Expiration Information
Lot# B5001 Exp 6/1/13
Recall Number: D-695-2013
Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes
05-29-2013
07-17-2013
5
Recall Profile & Regulatory Data
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Ongoing
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Lowlite Investments, Inc. D/B/A Olympia Pharmacy
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Nationwide and PR
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Alprostadil 2000 mcg/ml, compounded by Olympia Pharmacy, Orlando, FL
Batch or Lot Expiration Information
Lot# B5008 exp 12/31/13, K5030 Exp. 11/30/13, A5716 Exp. 8/31/13, C5121 Exp 9/12/13, and C5208 Exp 9/7/13
Recall Number: D-755-2013
Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes
05-29-2013
07-17-2013
1
Recall Profile & Regulatory Data
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Ongoing
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Lowlite Investments, Inc. D/B/A Olympia Pharmacy
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Nationwide and PR
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Methylcobalamin P 10/ml Creatine 40 mg/ml / Arginine 100 mg/ml Injection, compounded by Olympia Pharmacy, Orlando, FL
Batch or Lot Expiration Information
Lot# B0001 Exp 8/1/13
Recall Number: D-777-2013
Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes
05-29-2013
07-17-2013
1
Recall Profile & Regulatory Data
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Ongoing
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Lowlite Investments, Inc. D/B/A Olympia Pharmacy
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Nationwide and PR
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Progesterone EO 100 mg/ml Injection, compounded by Olympia Pharmacy, Orlando, FL
Batch or Lot Expiration Information
Lot# L3126 Exp 12/31/13
Recall Number: D-715-2013
Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes
05-29-2013
07-17-2013
1
Recall Profile & Regulatory Data
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Ongoing
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Lowlite Investments, Inc. D/B/A Olympia Pharmacy
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Nationwide and PR
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Cre-O-Pan Injection, compounded by Olympia Pharmacy, Orlando, FL
Batch or Lot Expiration Information
Lot# A3021 Exp 6/2/13
Recall Number: D-787-2013
Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes
05-29-2013
07-17-2013
24
Recall Profile & Regulatory Data
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Ongoing
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Lowlite Investments, Inc. D/B/A Olympia Pharmacy
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Nationwide and PR
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Trimix, compounded by Olympia Pharmacy, Orlando, FL
Batch or Lot Expiration Information
Lot# B5015 Exp 8/15/13, C50001 Exp 8/28/13, B5011 Exp 8/1/13, C42215 Exp 6/22/13, A5028 Exp 6/2/13, B5011 Exp 6/1/13, B5020 Exp 6/1/13, B50112 Exp 8/11/13, C4186 Exp 6/18/13, C4158 Exp 6/15/13, C4149 Exp 6/14/13, C4111 Exp 6/11/13, B4124 Exp 8/12/13, B4154 Exp 8/15/13, B4198 Exp 8/19/13, B4226 Exp 8/22/13, B4268 Exp 8/22/13, C40522 Exp 9/5/13, C4118 Exp 9/1/13, C4711 Exp 9/7/13, C41121 Exp 9/11/13, C4126 Exp 9/12/13 and B42715 Exp 8/27/13.
Recall Number: D-749-2013
Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes
05-29-2013
07-17-2013
1
Recall Profile & Regulatory Data
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Ongoing
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Lowlite Investments, Inc. D/B/A Olympia Pharmacy
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Nationwide and PR
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Lisinopril 20 mg/ml Injection, compounded by Olympia Pharmacy, Orlando, FL
Batch or Lot Expiration Information
Lot# A5028 Exp 6/2/13
Recall Number: D-766-2013
Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes
05-29-2013
07-17-2013
1
Recall Profile & Regulatory Data
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Ongoing
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Lowlite Investments, Inc. D/B/A Olympia Pharmacy
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Nationwide and PR
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
PEN-DEX-CHLOR Injection, compounded by Olympia Pharmacy, Orlando, FL
Batch or Lot Expiration Information
Lot# C5108 Exp 9/10/13
Recall Number: D-774-2013
Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes
05-29-2013
07-17-2013
1
Recall Profile & Regulatory Data
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Ongoing
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Lowlite Investments, Inc. D/B/A Olympia Pharmacy
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Nationwide and PR
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Potassium Phosphate Injection, compounded by Olympia Pharmacy, Orlando, FL
Batch or Lot Expiration Information
Lot# K5019 Exp 9/30/13
Recall Number: D-762-2013
Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes
05-29-2013
07-17-2013
1
Recall Profile & Regulatory Data
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Ongoing
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Lowlite Investments, Inc. D/B/A Olympia Pharmacy
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Nationwide and PR
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Naproxen 100 mg/ml Injection, compounded by Olympia Pharmacy, Orlando, FL
Batch or Lot Expiration Information
Lot# K5013 Exp 11/30/13
Recall Number: D-795-2013
Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes
05-29-2013
07-17-2013
1
Recall Profile & Regulatory Data
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Ongoing
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Lowlite Investments, Inc. D/B/A Olympia Pharmacy
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Nationwide and PR
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Xylazine 300 mg/ml Injection, compounded by Olympia Pharmacy, Orlando, FL
Batch or Lot Expiration Information
Lot# A5025 Exp 6/2/13
Recall Number: D-735-2013
Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes
05-29-2013
07-17-2013
1
Recall Profile & Regulatory Data
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Ongoing
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Lowlite Investments, Inc. D/B/A Olympia Pharmacy
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Nationwide and PR
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Gentamicin Sulfate 80 mg/ml Injection, compounded by Olympia Pharmacy, Orlando, FL
Batch or Lot Expiration Information
Lot# B5125 Exp 8/25/13
Recall Number: D-740-2013
Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes
05-29-2013
07-17-2013
3
Recall Profile & Regulatory Data
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Ongoing
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Lowlite Investments, Inc. D/B/A Olympia Pharmacy
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Nationwide and PR
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
HCG 125iu/0.25ml (550iu/ml), 3500iu and 10,000iu, compounded by Olympia Pharmacy, Orlando, FL
Batch or Lot Expiration Information
Lot# 500iu Lot A3504 Exp 8/31/13 3500iu Lot C3105 Exp 9/5/13 10000 iu Lot C3611 Exp 9/6/13
Recall Number: D-717-2013
Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes
05-29-2013
07-17-2013
2
Recall Profile & Regulatory Data
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Ongoing
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Lowlite Investments, Inc. D/B/A Olympia Pharmacy
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Nationwide and PR
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Detomidine 10 mg/ml Injection, compounded by Olympia Pharmacy, Orlando, FL
Batch or Lot Expiration Information
Lot# C5505 Exp 9/5/13 and C5107 Exp 9/7/13
Recall Number: D-745-2013
Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes
05-29-2013
07-17-2013
1
Recall Profile & Regulatory Data
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Ongoing
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Lowlite Investments, Inc. D/B/A Olympia Pharmacy
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Nationwide and PR
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Ketamine 100 mg/ml Injection, compounded by Olympia Pharmacy, Orlando, FL
Batch or Lot Expiration Information
Lot# B3411 Exp 8/11/13
Recall Number: D-708-2013
Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes
05-29-2013
07-17-2013
3
Recall Profile & Regulatory Data
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Ongoing
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Lowlite Investments, Inc. D/B/A Olympia Pharmacy
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Nationwide and PR
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Buprenorphine 0.3 mg/ml Injection, compounded by Olympia Pharmacy, Orlando, FL
Batch or Lot Expiration Information
Lot# B3727 Exp 12/27/13, C5511 Exp 9/5/13, and L5312 Exp 11/30/13
Recall Number: D-705-2013
Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes
05-29-2013
07-17-2013
1
Recall Profile & Regulatory Data
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Ongoing
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Lowlite Investments, Inc. D/B/A Olympia Pharmacy
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Nationwide and PR
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Betamethasone Phosphate/Acetate 6 mg/ml Injection, compounded by Olympia Pharmacy, Orlando, FL
Batch or Lot Expiration Information
Lot# A5810 exp 12/31/13
Recall Number: D-739-2013
Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes
05-29-2013
07-17-2013
2
Recall Profile & Regulatory Data
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Ongoing
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Lowlite Investments, Inc. D/B/A Olympia Pharmacy
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Nationwide and PR
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
HACC 270.1 Injection, compounded by Olympia Pharmacy, Orlando, FL
Batch or Lot Expiration Information
Lot# C0321 Exp 9/3/13 and B5627 6/4/13
Recall Number: D-718-2013
Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes
05-29-2013
07-17-2013
1
Recall Profile & Regulatory Data
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Ongoing
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Lowlite Investments, Inc. D/B/A Olympia Pharmacy
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Nationwide and PR
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Detomidine w/Xylazine 100 mg/mg Injection, compounded by Olympia Pharmacy, Orlando, FL
Batch or Lot Expiration Information
Lot# A5125 Exp 12/31/13
Recall Number: D-729-2013
Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes
05-29-2013
07-17-2013
1
Recall Profile & Regulatory Data
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Ongoing
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Lowlite Investments, Inc. D/B/A Olympia Pharmacy
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Nationwide and PR
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Fluphenazine 25 mg/ml Injection, compounded by Olympia Pharmacy, Orlando, FL
Batch or Lot Expiration Information
Lot# C5428 Exp 9/4/13
Recall Number: D-736-2013
Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes
05-29-2013
07-17-2013
1
Recall Profile & Regulatory Data
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Ongoing
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Lowlite Investments, Inc. D/B/A Olympia Pharmacy
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Nationwide and PR
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Glutathione 200 mg/ml Injection, compounded by Olympia Pharmacy, Orlando, FL
Batch or Lot Expiration Information
Lot# C5110 Exp 9/11/13
Recall Number: D-793-2013
Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes
05-29-2013
07-17-2013
1
Recall Profile & Regulatory Data
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Ongoing
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Lowlite Investments, Inc. D/B/A Olympia Pharmacy
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Nationwide and PR
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Vitamin B-Buildup Injection, compounded by Olympia Pharmacy, Orlando, FL
Batch or Lot Expiration Information
Lot# B0122 Exp 8/22/13
Recall Number: D-773-2013
Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes
05-29-2013
07-17-2013
6
Recall Profile & Regulatory Data
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Ongoing
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Lowlite Investments, Inc. D/B/A Olympia Pharmacy
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Nationwide and PR
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Polidocanol (0.75%, 1%, 3%, and 10%) Injection, compounded by Olympia Pharmacy, Orlando, FL
Batch or Lot Expiration Information
Lot# 0.75% Lot L5611 Exp 11/30/13 // 1% Lot b3001 Exp 6/19/13, B5014 Exp 8/14/13, and A5431 Exp 6/4/13 // 3% Lot A5808 Exp 12/31/13 // 10% Lot C5328 Exp 9/3/13
Recall Number: D-728-2013
Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes
05-29-2013
07-17-2013
1
Recall Profile & Regulatory Data
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Ongoing
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Lowlite Investments, Inc. D/B/A Olympia Pharmacy
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Nationwide and PR
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Estradiol Cypionate 2 mg/ml Test Cyp 50 mg/ml Injection, compounded by Olympia Pharmacy, Orlando, FL
Batch or Lot Expiration Information
Lot# C51212 Exp 8/12/13
Recall Number: D-734-2013
Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes
05-29-2013
07-17-2013
1
Recall Profile & Regulatory Data
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Ongoing
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Lowlite Investments, Inc. D/B/A Olympia Pharmacy
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Nationwide and PR
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Gentamicin 80 mg/ml Injection, compounded by Olympia Pharmacy, Orlando, FL
Batch or Lot Expiration Information
Lot# L3419 Exp 9/30/13
Recall Number: D-719-2013
Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes
05-29-2013
07-17-2013
1
Recall Profile & Regulatory Data
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Ongoing
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Lowlite Investments, Inc. D/B/A Olympia Pharmacy
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Nationwide and PR
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Dexamethasone Sodium Phosphate 6 mg/ml Injection, compounded by Olympia Pharmacy, Orlando, FL
Batch or Lot Expiration Information
Lot# L5504 Exp 8/31/13
Recall Number: D-700-2013
Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes
05-29-2013
07-17-2013
1
Recall Profile & Regulatory Data
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Ongoing
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Lowlite Investments, Inc. D/B/A Olympia Pharmacy
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Nationwide and PR
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Aminophylline 2.5% Injection, compounded by Olympia Pharmacy, Orlando, FL
Batch or Lot Expiration Information
Lot# A5630 Exp. 12/31/13
Recall Number: D-788-2013
Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes
05-29-2013
07-17-2013
2
Recall Profile & Regulatory Data
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Ongoing
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Lowlite Investments, Inc. D/B/A Olympia Pharmacy
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Nationwide and PR
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Tripelennamine 20 mg/ml Injection, compounded by Olympia Pharmacy, Orlando, FL
Batch or Lot Expiration Information
Lot# B5620 Exp 8/20/13 and A0322 Exp 12/31/13
Recall Number: D-741-2013
Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes
05-29-2013
07-17-2013
2
Recall Profile & Regulatory Data
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Ongoing
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Lowlite Investments, Inc. D/B/A Olympia Pharmacy
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Nationwide and PR
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Hippiron 20 mg/ml Injection, compounded by Olympia Pharmacy, Orlando, FL
Batch or Lot Expiration Information
Lot# B5006 Exp 8/6/13 and L5807 Exp 11/30/13
Recall Number: D-771-2013
Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes
05-29-2013
07-17-2013
1
Recall Profile & Regulatory Data
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Ongoing
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Lowlite Investments, Inc. D/B/A Olympia Pharmacy
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Nationwide and PR
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Phenylbutazone 200 mg/ml Injection, compounded by Olympia Pharmacy, Orlando, FL
Batch or Lot Expiration Information
Lot# A5224 Exp 8/1/13
Recall Number: D-786-2013
Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes
05-29-2013
07-17-2013
2
Recall Profile & Regulatory Data
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Ongoing
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Lowlite Investments, Inc. D/B/A Olympia Pharmacy
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Nationwide and PR
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Testosterone Cypionate (100 mg/ml & 200 mg/ml) Injection, compounded by Olympia Pharmacy, Orlando, FL
Batch or Lot Expiration Information
Lot# A5016 Exp 12/31/13 and B5028 6/5/13
Recall Number: D-791-2013
Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes
05-29-2013
07-17-2013
2
Recall Profile & Regulatory Data
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Ongoing
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Lowlite Investments, Inc. D/B/A Olympia Pharmacy
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Nationwide and PR
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Vitamin B12 (3000 mcg/ml & 5000 mcg/ml) Injection, compounded by Olympia Pharmacy, Orlando, FL
Batch or Lot Expiration Information
Lot# B0020 Exp 8/20/13 and C31011 Exp 9/10/13
Recall Number: D-694-2013
Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes
05-29-2013
07-17-2013
1
Recall Profile & Regulatory Data
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Ongoing
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Lowlite Investments, Inc. D/B/A Olympia Pharmacy
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Nationwide and PR
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Adenosine-Mono-Phosphate Injection, 200 mg/ml, compounded by Olympia Pharmacy, Orlando, FL
Batch or Lot Expiration Information
Lot# A5631 exp 12/31/13
Recall Number: D-692-2013
Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes
05-29-2013
07-17-2013
1
Recall Profile & Regulatory Data
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Ongoing
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Lowlite Investments, Inc. D/B/A Olympia Pharmacy
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Nationwide and PR
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Acetyl-D-Glucosamine w/Chondroitin 200 mg/ml, compounded by Olympia Pharmacy, Orlando, FL
Batch or Lot Expiration Information
Lot# A5911 exp 12/31/13
Recall Number: D-760-2013
Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes
05-29-2013
07-17-2013
3
Recall Profile & Regulatory Data
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Ongoing
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Lowlite Investments, Inc. D/B/A Olympia Pharmacy
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Nationwide and PR
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
MICC (Methionine, Inositol, Choline, Cyanocobalamin, Chromium) Inj and MICC 25/50/330 Inj, compounded by Olympia Pharmacy, Orlando, FL
Batch or Lot Expiration Information
Lot# Lots: L5306 Exp 11/30/13 and C5414 Exp 9/21/13 25/50/330 Lot L5118 Exp 12/31/13
Recall Number: D-701-2013
Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes
05-29-2013
07-17-2013
3
Recall Profile & Regulatory Data
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Ongoing
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Lowlite Investments, Inc. D/B/A Olympia Pharmacy
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Nationwide and PR
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Atipamezole 10 mg/ml Injection, compounded by Olympia Pharmacy, Orlando, FL
Batch or Lot Expiration Information
Lot# L3628 Exp 12/31/13, B5306 Exp 8/6/13, and C3120 Exp 9/20/13
Recall Number: D-746-2013
Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes
05-29-2013
07-17-2013
1
Recall Profile & Regulatory Data
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Ongoing
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Lowlite Investments, Inc. D/B/A Olympia Pharmacy
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Nationwide and PR
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Ketoprofen Solution 10% Injection, compounded by Olympia Pharmacy, Orlando, FL
Batch or Lot Expiration Information
Lot# C5122 Exp 9/22/13
Recall Number: D-713-2013
Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes
05-29-2013
07-17-2013
2
Recall Profile & Regulatory Data
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Ongoing
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Lowlite Investments, Inc. D/B/A Olympia Pharmacy
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Nationwide and PR
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Chlorpromazine HCL 100 mg/ml Injection, compounded by Olympia Pharmacy, Orlando, FL
Batch or Lot Expiration Information
Lot# C5812 Exp 9/8/13 and L4317 Exp 6/30/13
Recall Number: D-714-2013
Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes
05-29-2013
07-17-2013
1
Recall Profile & Regulatory Data
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Ongoing
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Lowlite Investments, Inc. D/B/A Olympia Pharmacy
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Nationwide and PR
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Clenbuterol 0.03mg/ml Injection, compounded by Olympia Pharmacy, Orlando, FL
Batch or Lot Expiration Information
Lot# A0107 Exp 01/31/14
Recall Number: D-730-2013
Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes
05-29-2013
07-17-2013
1
Recall Profile & Regulatory Data
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Ongoing
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Lowlite Investments, Inc. D/B/A Olympia Pharmacy
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Nationwide and PR
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Furosemide 50 mg/ml Injection, compounded by Olympia Pharmacy, Orlando, FL
Batch or Lot Expiration Information
Lot# A5029 Exp 11/30/13
Recall Number: D-732-2013
Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes
05-29-2013
07-17-2013
1
Recall Profile & Regulatory Data
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Ongoing
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Lowlite Investments, Inc. D/B/A Olympia Pharmacy
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Nationwide and PR
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Gentamicin 0.3% Injection, compounded by Olympia Pharmacy, Orlando, FL
Batch or Lot Expiration Information
Lot# A5308 Exp 6/30/13
Recall Number: D-699-2013
Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes
05-29-2013
07-17-2013
1
Recall Profile & Regulatory Data
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Ongoing
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Lowlite Investments, Inc. D/B/A Olympia Pharmacy
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Nationwide and PR
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Aminocaproic Acid 0.5mg/ml Injection,compounded by Olympia Pharmacy, Orlando, FL
Batch or Lot Expiration Information
Lot# B5505 Exp. 08/06/13
Recall Number: D-696-2013
Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes
05-29-2013
07-17-2013
1
Recall Profile & Regulatory Data
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Ongoing
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Lowlite Investments, Inc. D/B/A Olympia Pharmacy
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Nationwide and PR
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Altrenogest 50 mg/ml Injection, compounded by Olympia Pharmacy, Orlando, FL
Batch or Lot Expiration Information
Lot# L5012 exp. 11/30/13
Recall Number: D-733-2013
Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes
05-29-2013
07-17-2013
2
Recall Profile & Regulatory Data
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Ongoing
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Lowlite Investments, Inc. D/B/A Olympia Pharmacy
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Nationwide and PR
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Gentamicin 300 mg/ml Injection, compounded by Olympia Pharmacy, Orlando, FL
Batch or Lot Expiration Information
Lot# B5014 Exp 8/13/13 and C3913 Exp 9/9/13
Recall Number: D-769-2013
Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes
05-29-2013
07-17-2013
1
Recall Profile & Regulatory Data
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Ongoing
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Lowlite Investments, Inc. D/B/A Olympia Pharmacy
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Nationwide and PR
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Phenobarbital 62. 5mg/ml Injection, compounded by Olympia Pharmacy, Orlando, FL
Batch or Lot Expiration Information
Lot# B5128 Exp 8/28/13
Recall Number: D-737-2013
Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes
05-29-2013
07-17-2013
3
Recall Profile & Regulatory Data
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Ongoing
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Lowlite Investments, Inc. D/B/A Olympia Pharmacy
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Nationwide and PR
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Guanabenz 8 mg/ml Injection, compounded by Olympia Pharmacy, Orlando, FL
Batch or Lot Expiration Information
Lot# C3621 Exp 9/21/13, L3618 Exp 10/31/13, and A0224 Exp 6/30/13
Recall Number: D-693-2013
Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes
05-29-2013
07-17-2013
1
Recall Profile & Regulatory Data
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Ongoing
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Lowlite Investments, Inc. D/B/A Olympia Pharmacy
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Nationwide and PR
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Acepromazine 25 mg/ml Injection, compounded by Olympia Pharmacy, Orlando, FL
Batch or Lot Expiration Information
Lot# B0112 exp 08/31/13
Recall Number: D-697-2013
Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes
05-29-2013
07-17-2013
2
Recall Profile & Regulatory Data
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Ongoing
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Lowlite Investments, Inc. D/B/A Olympia Pharmacy
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Nationwide and PR
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Amikacin Sulfate 250 mg/ml Injection, compounded by Olympia Pharmacy, Orlando, FL
Batch or Lot Expiration Information
Lot# B5501 Exp 8/5/13 and B3025 Exp 12/31/13
Recall Number: D-712-2013
Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes
05-29-2013
07-17-2013
1
Recall Profile & Regulatory Data
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Ongoing
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Lowlite Investments, Inc. D/B/A Olympia Pharmacy
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Nationwide and PR
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Ceftiofur GM vial 50 mg/ml Injection, compounded by Olympia Pharmacy, Orlando, FL
Batch or Lot Expiration Information
Lot# K5520 Exp 11/23/13
Recall Number: D-756-2013
Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes
05-29-2013
07-17-2013
1
Recall Profile & Regulatory Data
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Ongoing
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Lowlite Investments, Inc. D/B/A Olympia Pharmacy
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Nationwide and PR
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Methylcobalamin 1 mg/ml / Folic Acid 2.5 mg/ml Injection, compounded by Olympia Pharmacy, Orlando, FL
Batch or Lot Expiration Information
Lot# L3326 Exp 6/30/13
Recall Number: D-792-2013
Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes
05-29-2013
07-17-2013
1
Recall Profile & Regulatory Data
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Ongoing
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Lowlite Investments, Inc. D/B/A Olympia Pharmacy
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Nationwide and PR
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Vitamin B12 Cyanocobalamin 5000 mcg Injection, compounded by Olympia Pharmacy, Orlando, FL
Batch or Lot Expiration Information
Lot# L5203 Exp 11/30/13
Recall Number: D-782-2013
Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes
05-29-2013
07-17-2013
10
Recall Profile & Regulatory Data
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Ongoing
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Lowlite Investments, Inc. D/B/A Olympia Pharmacy
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Nationwide and PR
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Sodium Tetradecyl Sulfate (0.125%, 1%, 2.5%, 3%, and 4%) Injection, compounded by Olympia Pharmacy, Orlando, FL
Batch or Lot Expiration Information
Lot# 0.125% Lot B3505 Exp 8/1/13 // 1% Lots C5001 Exp 9/30/13, C5406 Exp 9/4/13, and C5306 Exp 9/30/13 // 2.5% Lot C5101 Exp 9/30/13 // 3% Lots B5120 Exp 10/31/13, C5301 Exp 9/30/13, B5428 Exp 6/4/13, and C5212 Exp 9/21/13 // 4% Lot C5301 Exp 9/30/13
Recall Number: D-709-2013
Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes
05-29-2013
07-17-2013
1
Recall Profile & Regulatory Data
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Ongoing
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Lowlite Investments, Inc. D/B/A Olympia Pharmacy
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Nationwide and PR
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Caco/Copper 6. 2 mg/ml Injection, compounded by Olympia Pharmacy, Orlando, FL
Batch or Lot Expiration Information
Lot# L5610 exp 11/30/13
Recall Number: D-763-2013
Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes
05-29-2013
07-17-2013
1
Recall Profile & Regulatory Data
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Ongoing
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Lowlite Investments, Inc. D/B/A Olympia Pharmacy
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Nationwide and PR
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Neomycin / Polymyxin / Dexamethasone Ophthalmic Drops, compounded by Olympia Pharmacy, Orlando, FL
Batch or Lot Expiration Information
Lot# A5531 Exp 6/5/13
Recall Number: D-748-2013
Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes
05-29-2013
07-17-2013
1
Recall Profile & Regulatory Data
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Ongoing
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Lowlite Investments, Inc. D/B/A Olympia Pharmacy
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Nationwide and PR
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Lipotoxin Injection, compounded by Olympia Pharmacy, Orlando, FL
Batch or Lot Expiration Information
Lot# A3121 Exp 9/30/12
Recall Number: D-731-2013
Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes
05-29-2013
07-17-2013
1
Recall Profile & Regulatory Data
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Ongoing
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Lowlite Investments, Inc. D/B/A Olympia Pharmacy
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Nationwide and PR
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Gaba 50 mg/Mag Sulfate 50 mg/Taurine/Theanine 50 mg/ml Injection, compounded by Olympia Pharmacy, Orlando, FL
Batch or Lot Expiration Information
Lot# C3729 Exp 9/7/13
Recall Number: D-744-2013
Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes
05-29-2013
07-17-2013
2
Recall Profile & Regulatory Data
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Ongoing
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Lowlite Investments, Inc. D/B/A Olympia Pharmacy
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Nationwide and PR
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
ITPP 50 mg/ml DMG 100 mg/ml Injection, compounded by Olympia Pharmacy, Orlando, FL
Batch or Lot Expiration Information
Lot# A3113 Exp 7/1/13 and A3401 Exp 2/1/14
Recall Number: D-711-2013
Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes
05-29-2013
07-17-2013
1
Recall Profile & Regulatory Data
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Ongoing
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Lowlite Investments, Inc. D/B/A Olympia Pharmacy
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Nationwide and PR
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Cal-Phos 1000 Injection, compounded by Olympia Pharmacy, Orlando, FL
Batch or Lot Expiration Information
Lot# A5211 Exp 12/31/13
Recall Number: D-723-2013
Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes
05-29-2013
07-17-2013
1
Recall Profile & Regulatory Data
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Ongoing
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Lowlite Investments, Inc. D/B/A Olympia Pharmacy
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Nationwide and PR
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Diphenhydramine 50 mg/ml Injection, compounded by Olympia Pharmacy, Orlando, FL
Batch or Lot Expiration Information
Lot# A3804 Exp 12/31/13
Recall Number: D-764-2013
Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes
05-29-2013
07-17-2013
3
Recall Profile & Regulatory Data
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Ongoing
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Lowlite Investments, Inc. D/B/A Olympia Pharmacy
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Nationwide and PR
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Oxytocin 20 units/ml Injection, compounded by Olympia Pharmacy, Orlando, FL
Batch or Lot Expiration Information
Lot# B5019 Exp 10/31/13, B3525 Exp 8/25/13 and B3122 Exp 8/22/13
