Why it was recalled
Lack of Assurance of Sterility: Martin Avenue Pharmacy, Inc. is conducting a voluntary recall of all compounded sterile preparations within expiry. The recall is being initiated in connection with a recent FDA inspection due to observations associated with certain quality control procedures that present a risk to sterility assurance.
Product description
Peng/proc/strep/chlor/hyos (penicillin G, procaine, streptomycin sulfate, chlorpheniramine maleate, hyoscyamine sulfate) (vet) injection suspension packaged in an amber glass injectable vial, Martin Avenue Pharmacy, 1247 Rickert Dr, Naperville, IL.
Lot numbers, UPCs & expiration codes
Lot Number: 03312014@29, Exp 9/27/2014; 06262014@20, Exp 12/23/2014
Where it was sold
Nationwide
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0110-2015
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Aug 27, 2014
- FDA report date
- Nov 5, 2014
- Quantity
- 900 mL
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Martin Avenue Pharmacy, Inc.
Original FDA data
Every field from FDA enforcement report D-0110-2015, exactly as published.
Show all FDA fields
- City
- Naperville
- State
- IL
- Status
- Terminated
- Country
- United States
- Event ID
- 69152
- Address
- 1247 Rickert Dr
- Code information
- Lot Number: 03312014@29, Exp 9/27/2014; 06262014@20, Exp 12/23/2014
- Postal code
- 60540-1008
- Report date
- Nov 5, 2014
- Product type
- Drugs
- Recall number
- D-0110-2015
- Classification
- Class II
- Recalling firm
- Martin Avenue Pharmacy, Inc.
- Product quantity
- 900 mL
- Termination date
- May 31, 2018
- Reason for recall
- Lack of Assurance of Sterility: Martin Avenue Pharmacy, Inc. is conducting a voluntary recall of all compounded sterile preparations within expiry. The recall is being initiated in connection with a recent FDA inspection due to observations associated with certain quality control procedures that present a risk to sterility assurance.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Peng/proc/strep/chlor/hyos (penicillin G, procaine, streptomycin sulfate, chlorpheniramine maleate, hyoscyamine sulfate) (vet) injection suspension packaged in an amber glass injectable vial, Martin Avenue Pharmacy, 1247 Rickert Dr, Naperville, IL.
- Distribution pattern
- Nationwide
- Recall initiation date
- Aug 27, 2014
- Initial firm notification
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Center classification date
- Oct 29, 2014